ALDX - Earnings call transcript Q1 2022 | Aldeyra Therapeutics, Inc.

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 First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to hand over the conference to company's Chief Financial Officer, Mr. Joshua Reed. sir. ahead, go Please

Joshua Reed

our of With Executive are incoming A Officer; we the release statements This everyone. morning's this ended performance the President is XX, March Interim Todd and morning, reporting press the conference a contains Chief and issued forward-looking press XXXX. results me future morning, for Dr. quarter today Brady, CFO. financial Good available & events Investors future Bruce that the copy Please of section note of regarding and Media our release on Aldeyra. website, www.aldeyra.com. call Greenberg,

They clinical risks development, and future from portions product risks review are include, or trials, our not future accurately concerning or result results control potential position; operations, not today analysis submission of commercialization; statements possible our from quality These to, and and of trials, applications; of events. indications assumed and information results opportunities. or timing anticipated the growth upon statements trials; views data. financial plans us trials available predict systems-based same of the uncertainties, results continuing are Forward-looking regarding subject but for are the to potential candidates expectations that to for current and our may different and regulatory future drug the approaches. Aldeyra's clinical, runway; of potential clinical including clinical The and cash new statements clinical on our limited expenses, and assumptions based based and reflect the of projected or Aldeyra's

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

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

many will opportunity company position as the space. let leaving I Though a life not of another to Aldeyra week, take I be you As know, could next CFO it less ideal, the was in an was of publicly-traded pass. sciences than timing

team It Board While along transitions seeing you know that the Directors, accomplished you X.X this part to depth now natural are look of controller and a the work pride it as the skills Bruce outstanding success. for forward the that to been do Todd, more him Greenberg, taken of at working will I Aldeyra's Dr. build particular incoming he'll we proud has years continued and with entire of CFO, our years. with friendships of public our team exemplifies post. much knowledge. both. qualified science Aldeyra to Aldeyra highly with is XXXX you of I'm in than of and turn closely the operating always I've experience, Bruce helping and Bruce company's since, finance gain a and over companies. an over the hired what the strong at Brady. XX the I job. in Having past call exceedingly business, gratifying way. provided relish has make

Dr. Todd Brady

and sincere our for programs appreciation and years. joining the Thank of work discuss to our his Thank you, convey Joshua. first recent dedication for you results. we Good as let past morning, But Joshua before clinical me do financial quarter the review we everyone. over X.X that, progress us my

to experience, want business financial will on of chapter the truly transition. wish of us as I All Vice make he I as knowledge Aldeyra that seamless his him with our begins next success also Treasurer. Bruce's industry CFO, the his Interim expect over President, this Finance, Bruce and several a and at congratulate past career. appointment much deep coupled of And years,

recent our accomplishments development an and and which Aldeyra. retinal highlights, continue one QX year executing Turning for key disease we to It milestones the between research and our our the R&D our in be clinical a of on what to plan catalyst-rich programs. we ocular, marked for systemic, our start strategic quarter exciting in will company, Day, was believe

We prescription available disease Currently treatments. in XX platform drug dissatisfied midyear approval a pharmaceutical million the the our molecules been that lead reproxalap often are immunological estimated require modest RASP, of affects implicated a submission are wide of Dry target current adults of to care It's even months percentage is and in drug eye an are eye dry continuing represent XX Reproxalap standard an novel toward for expected topical advance which a whom large comprised U.S., range pro-inflammatory eye disease. development disease. demonstrate targeting with diseases. discovery to in years since first asset NDA of in a of therapies dry small the efficacy. nearly

trial pattern. As result, the disease. toward that TRANQUILITY-X the in first new We dry in of quarter, took that a significantly a underserved. enrollment therapy eye reproxalap eye envision changes dry We remains vision another market disease in III introducing Phase completing that step

dosing That have the outcomes, results of XX% completed TRANQUILITY-X statistical drug simulations received achieved. eye results trials, on our I that ocular are mechanism, indicate plans Based to precise eye submission. of alpha our day for day was implications TRANQUILITY previously during both been interactions for simulated product dosing potential the alpha many timing from continuing II trial, have review equally endpoints first TRANQUILITY-X, the analytical ocular time of or across on the criteria if TRANQUILITY-X the We trial the was in the want the tests label, and we is We're the some TRANQUILITY and remain second of or chamber. redness nature of if a planned on either approved, the describing the either guidance, confirm test on TRANQUILITY-X that achieved, roughly of primary of endpoints, implemented redness we've Phase positive. multiplicity dry dry of second to per the and an potential in the endpoint vehicle Schirmer is, least schedule distributes TRANQUILITY-X data report met. at FDA for disease NDA over Because for The Schirmer sharing FDA test Sherer quarter. the success, investors primary regarding significance to to questions and on the redness and of spend of will of TRANQUILITY-X,

achieved next support TRANQUILITY-X. outcome Type after in a submission are major and generate will trials a pivotal test ocular tests significantly designed have these be pivotal Pending is trials Our so X or could qualified are may drug following X meeting, interaction trials soon for are submission. TRANQUILITY-X, results impact signs, as in Either as either trials of to to disease expected FDA TRANQUILITY-X. TRANQUILITY-X of for for serve time timing. the the an to trials ocular with X Both redness of Schirmer results Two could also or represent eye submit the if NDA We not reproxalap the trial first the pre-NDA Schirmer redness chamber trials of addition for trial. the both a to B demonstration NDA of ongoing, symptoms. Schirmer test X-day and in objective crossover activity additional signs, dry

U.S. the earlier allergic trial study completed are disease, in the In a similar improvement this INVIGORATE significant criteria the in trial, In in also itching. the ocular our clinical of March, primary which Phase indicates more INVIGORATE, allergen ocular least in from in activity consistent previously our III itching inflammation. pathologic affects RASK from at reduction pharmacodynamic proof-of-concept and Based in Enrollment achieved than of XXXX. ocular to year and adults trials III eye statistically secondary data that addition endpoint of and asthma, announced trial data endpoint outcomes signs modeling our patient-reported of in initiated trials, key design, is demonstrated trial At first-in-class in XX% COVID-XX with conjunctivitis, INVIGORATE-X primary our XX broad-based of we oral We endpoint results to redness. clinical alone. the reproxalap and and R&D condition of Phase that those INVIGORATE-X substantially dry a Day expect of chamber simulation demonstrated conduct topline on million modulator, infection. endpoints, ADX-XXX, psoriasis, ADX-XXX

clinical have ADX-XXX advanced announced Phase indications. II in clinical Day, to As X at new trials we we R&D

multiple initiated clinical toxicity XXXX syndrome later program Our Phase positioning over and have and remainder in are ethanol the expected systemic for our II chronic this clinical to change disease minimal clinical year, and in XXXX. already be Sjogren-Larsson trials initiated. Phase II cough of milestones trials

vitreous retinal II our for also Duke been formulation We diseases. ADX-XXXX, continue in University conducted pigmentosa, clinical trial compatible at retinitis initiated. of advance has methotrexate Medical An Center, Phase to investigator-sponsored orphan

expected In this Results vitreoretinopathy. of enrollment GUARD from completed trials both quarter, the addition, proliferative second we III in the in of X in Part first half in trial the of these year. Phase are

clinical Now I'll our in turn the diseases. treatment of future which progress I developing platforms Joshua, potential summarize our novel immune-mediated and will the after for call recent over to

Joshua Reed

be cash plan, sufficient equivalents, Thank existing were of we Based equivalents, on you, XXXX, diseases. securities and to cash operating $XXX.X million. Cash, if marketable through development March including ocular commercialization approved, expenses our projected operating securities XX, new continued current and candidates product drug and initial of systemic marketable cash, in to as Todd. our potential immune-mediated currently fund submissions, reproxalap, our XXXX, of application end the and of expect

programs, increase the results, share, of a operating period million total million, our Moving the in comparable $X.XX compared for of have is administrative to for The same the as increase expenditures. $XX.X development administrative first and $X.XX operating and research an to with of same on the our period share, net million million cost period consulting due or Research $X.X development research The and were compared and $XX.X in million, clinical per clinical with in $X.X from per or XXXX. development is expenses expenses same period loss $X.X were of and million, increase net expenses $XX.X XXXX. of from million with for to expenses. with primarily loss compared increases XXXX. well million, as Total million, and for quarter primarily was related trials were in expenses in Losses the $X.X general million of compared $X.X expenditures. XXXX. General $XX.X resulted XXXX $XX.X

Now the closing to back call I'll comments. Todd hand for

Dr. Todd Brady

Joshua. you, Thank

XXXX of quarter with year. and about our the milestones regulatory this as enthusiasm as the half and tremendous for We planned clinical clinical have well begun the second progress, second

to potential of fact, rapid and significant onset looking disease this to date, broad disrupt we're believe across dry III -- announcing observed of activity unique eye signs the and to reproxalap this year a Phase trial that quarter. forward and the TRANQUILITY-X Given action in market, results symptoms the we later has

retinal disease in reproxalap, happy systemic that, long-term take to platforms Beyond represent we'd our underappreciated. for questions. our substantial that, and significantly view, your be remains creation near-term value With opportunities and Operator?

Operator

comes [Operator first Our at Instructions] today from Oppenheimer. Justin Kim question

Justin Kim

reproxalap on overview helpful. ongoing trials The has been

X readout, the you about bit As having studies? upcoming relates the TRANQUILITY-X these to data the as And little just fileable for of motivation team pivotal the following just could test? you Schirmer in approaches trials could TRANQUILITY-X? discuss of additional Are TRANQUILITY-X to [cure] the on X redness serve -- it a confidence the the or basis sort in package for of us for place a intended studies clarify

Dr. Todd Brady

conversations agency, our the confident NDA we're package. strength the in of with quite on Based our submission

package is submitted. most would submit to the In ever fact, dry we package say, disease comprehensive eye the intend I arguably,

an years eye objective sign sign. a as Schirmer been dry many ago, or dry Most there have As disease, with redness eye dry with disease. whether redness RESTASIS sign think beginning disease is test Recently, serve has used plenty precedent generic of far Schirmer approvable drugs, for an use as steroid I of of as can in approved eye for either. test the as

data as Schirmer either crossover think chamber the fairly the clear the package. Justin, to on the whatever for that know, the additional is, think trial, better the your of accept the so clear, designed X-day your very not Aldeyra or running trials So, you support number cost is will that support that And trial up stronger of shots back And is precedent X-day The I or the to the as In fortunate is the disease -- are with patients I trials, of that essentially trials the preponderance have FDA able evidence, and trials redness. considers test package. odds look and think cash a more X- wise package I Schirmer event to reason, to clinical number thus, approval. mentioned, is, test NDA TRANQUILITY-X. our TRANQUILITY-X in responsible clinical we have nominal I we position two and -- eye package. dry submission our use of FDA we goal the Broadly, rapid from will tested forth submission of being to run additional of and the submit

Justin Kim

Got it. had filing Got mentioned from Understood. in more I the timeline, know regards Maybe one is of With it. sort me. you midyear cards. that just a to

critical that going how path. wondering is progress Just study on long-term the of and whether safety the remains of the sort still

Dr. Todd Brady

the of for the remains trial The path. on factor safety safety The is gating NDA. the trial critical submission the

subjects, exposed to requires months. your least commercial patients, or at your for you XXX to dosing at the As regimen XX formulation XXX commercially been FDA have know, proposed

as trial We the randomization, to is a patients on X:X are vehicle. many vehicle, are drug that masked how versus to drug is safety

However, to based information have on a date, the remain we on for track that we midyear the NDA. of submission believe we

Justin Kim

project. on Congrats the Great. Great.

Operator

comes from Marc Leerink. SVB Our next of question Goodman

Marc Goodman

is the all, given Todd, market. the if a right making Bruce, a Two with that what's the and you generic? anything just can at there changed, eye a going partnered, give potentially product or Yes. there to this confidence can sense for there's dry with deal? and first, RESTASIS licensed you the of of flavor who's give much that us dynamics could that transition driver at is relationship second, has questions; And be now going of happening CFO, then how a us that key be there

Dr. Todd Brady

the some in of you for coverage in Thanks for recall I initial Allergan launched. were of days. Mark. involved back And RESTASIS question was it's around sure, you an you, For when question. ironic And were those the because

I RESTASIS. think XXXX date for was the launch

do has RESTASIS cons. becomes is about will RESTASIS. its many The payers now is would is generic month. almost failed which any when as The disease discontinuation in generic, mentioned, step-through, patients The time available. is generic you've many, that a have As many, already pros certainly of a median require con pro they and RESTASIS

I a think after so therapy, have patients approximately XX% discontinued or of of year RESTASIS.

an issue I might So, think, will stepping less through apparent. generic a be be RESTASIS initially RESTASIS, and/or than of

significant. as was dose, why choice, topically head-to-head tolerated was we Xiidra position is disease showed vision X that installation taste Xiidra. than trial, we've trials the Our the now has And that reproxalap goal there which that of those better a dose there versus were is been Xiidra after after of that hour is run drug. than less other to In branded than eye Xiidra, all was drug which reproxalap single only novel, one less administered findings paper and disturbance blurry statistically That over an published. dry

free find PubMed of can it charge. You on

with exacerbation with Xiidra face We dry of but and slower eye symptoms reproxalap-treated essentially interested is noxious. Xiidra-treated -- Again, of that our visual -- how well And RESTASIS. call were in chamber our These choice. is positioning patients of be a escalation either subjects the than generic forced face the in eye symptoms, branded seeing drug Hence, that the the -- we escalate a drug head-to-head in we drug that we does dry a during showed goal ran what chamber. trial against less to is tasking. our are was patients. dry This air chambers versus no-humidity protected blown second in the chamber. air in in The eye

about Let your me question partnering. the answer

demand front-of-the-eye there there reasons. drug, the fairly considerable of is just from innovative action process, many development can isn't patients, broadly that the the business RESTASIS drugs anterior eye many given the modest rife involved as class branding, in Xiidra. a eye been prepared forth, of has dry reason of dry onset think focused commercial led said not and commercial only disease therapies if And comments, the a new development whole two of a I also is affect that side development development the of not disease in satisfied, that side for and for you few innovation. now pharmacology, now there's at on activity Unfortunately, the patient Kelly applied the fact be activity ongoing much new with given eye the the I physician whole aspects. comments one product my is of and And diseases Reproxalap to look potential represents of status pipeline, much. dry that not our just inflammation, eye, in One course, but reproxalap's is, the today's conversations market the for not Mizer. I pipeline, apparent of lead is ophthalmology is today's but for body. either new second it's also in The think drug positioning, drugs lengthy so for of but business often really discussions is those which years, on segment just by rest has fence, the representative, aspects, generally, are disease the the label fence my only not late-stage of or only either and

Operator

Citi. next Yigal comes Our question from Nochomovitz from

Yigal Nochomovitz

aldehyde you've involvement. in you are it, on indications obviously mutually presentation, orthogonal the commonality clinical So, cough, mentioned announced with albeit of indications these R&D underlying minimal X at of X face and XXX, change, the chronic SLS. of the toxicity, for And common terms Day, new as the seems ethanol it

role you terms ranks POS, progression? lowest rank So, and of X the the disease ranks being aldehyde which highest biochemistry that which in based with in on to of were these said, if

Dr. Todd Brady

modulators. allows you something question asked generally, That that to And the would and the toxicity, precisely we're ADX-XX I argue more we're ADX-XXX. the least are think that at as when pharmacodynamic related ethanol we smiling different particularly RASP, applicability demonstrate because are Sjogren-Larsson because probably is, acetaldehyde, inflammation. which syndrome, about activity error we metabolism R&D and enzyme trap acetaldehyde, thereby, likely is is able in RASP ADX-XXX ADX-XXX Day, inflammation likely I are to broad is a diseases that Sjogren-Larsson tremendous is a we a to think lot potential been sense, Of different and complementary that, syndrome, diseases as particular, of that have which by Ethanol, at us should done of a featured a mutation that and/or here. generate that with And an an diminish are activity. have other that point kinds what trapped most broad the shown benefit, in advantage. be mediates in I'm doing consume which was of RASP out, diseases, derive test fatty diseases caused inborn that have you as a by metabolizes test ethanol, to in drug. and aldehydes, of it's we inflammatory aldehydes, genetic of to to

as would in of in toxicity ethanol I best activity, in and diseases, So, we're such terms pharmacodynamic positioned suspect that SLS. white

the tested minimal and the chronic of at autoimmune psoriasis. inflammation, intentionally Day. spectrum, had For change We disease; the an that data optimistic we that of on which R&D inflammatory one different presented kinds of end also cough, we I'm diseases, so and optimistic, is, I'm disease because are

had all thus, we clinical think On each either allergic inflammatory of asthma. is spectrum, diseases which remain an the optimistic pharmacodynamic the disease, In our and or we we activity, case, other I about end had forward with favorite as child. we're indications beginning well. case, little optimistic discussing this toxicity, in But bit and about X later like look to ethanol results, a year. our your the It's selecting

Yigal Nochomovitz

questions That's very, very housekeeping it. and eye had I on just incremental Got color. Okay. helpful kind two dry TRANQUILITY. of

pretty data TRANQUILITY-X. for you're to just press comment completed the made I was review to would the co-primary be continuing that that terms for bit little I in redness hammered a everything Schirmer's from you how was plans So, the finalize I TRANQUILITY-X. guess analytical away puzzled and analyzed a I the thought much in by TRANQUILITY release trial statement. guess of in

on you analytical say finalizing. if you don't when you what still mean mind elaborating So, some need just plans

Dr. Todd Brady

to to to this alpha alpha simulation be your alpha and The additional split the nominally, modeling the X.XX. positive the TRANQUILITY-X you will Schirmer Well, test. allocated to do on alpha dear to much allocated so X.XXX simulating the X.XX is divide X.XXX eloquently. be for and is, that outcome. to you heart, you've share, has to demonstrate alpha near Schirmer share analysis results Yigal, much of redness redness a and alpha half less answer and has so -- because than could and how the That with done, p-value Typically, is the how is to alpha, you you test. is the When give to in kudos

of However, on the outcome the depend we've from based will exact because by is run TRANQUILITY-X, alpha allocation, on in of That's primarily I largest our date. the of trials simulations TRANQUILITY-X, the to analysis. mean ongoing what ongoing that the case, data

allocation decided have We the for and TRANQUILITY-X. precise across Schirmer tests redness not alpha

the be expect allocation this I at X:X point. roughly However, to

Yigal Nochomovitz

Okay. one question. Understood. then simulations. will my there's I other refinement, reburn final If a And

middle that going before, the of just of exposure. to the you but middle XXX to of this given guidance the Is NDA goal, filing year? correct presumably hit on I of patients so with for my XX year, safety, drug that the understanding sort alluded months think with you're your

Dr. Todd Brady

the X XXX guidance, of with submission exposure. months is, data; X FDA Per of with occur can that NDA months patients

However, of update of the X by the XXX-day NDA remainder exposure the submitted. submission, be months standard needs to following

of which the X remainder then completion X typically I to sponsor to months the submit, months initial days think of exposure, the allowed the covers XXX and most with later, NDA sponsors months. XX X of the submit

Operator

Jefferies. question at is Kelly from Our Shi next

Kelly Shi

your dry classic help X from curious, following and more So, Would I'm eye endpoint, since test this repro's strategy drugs to to be differentiation significant TRANQUILITY trials will trials Schirmer's if new these scenario? [Indiscernible] prescribers? would only for Schirmer's TRANQUILITY in be dry eye other just label, a included product of convey is what test the in

Dr. Todd Brady

a That's a been I the on large really interesting the side optometry leaders, of opinion with have side. number key question that ophthalmology exploring both Kelly on Mizer and and

a dry we lot important it's about company, time XX% of to with is key is What which a that optometry considerable amount our matters from leaders eye the as is spend ophthalmology. interactions the are of of what and remember sign? question. spent potential to a sign? side thought on scripts label is, your We of and think terms derived so right with well The scenarios, gets in I is optometrists, opinion redness dealing as test consistent, What if the as the that answer symptoms. Schirmer leaders if

on or we're and seems is X for less This on can obviously, having a is the label. to and patient dry XX better, paradigm your have wait key expect wait better way patient reproxalap, provider, therein versus data feel or you're lies months to a or you your talking. on your to better, Xiidra, advantage X or you is healthcare And the if disease represent feel to in the to ophthalmologist, a the you whom feel comments healthcare that's depends key provider Instead optometrist really of an an according month want we quickly. said driver As want with the of patients and our prepared head-to-head we Whether that particular the why redness reproxalap relevant, Schirmer seconds. shift be, in to eye the treated. we to competitive months label

for side, I patients optometry think redness, of on may the be a because slight complain there preference redness.

eye As may dry care patients sign only I about. have the be redness before, that said disease

that's other as preference can past. signs test, most makes generate and more drug And used it the should that seemed Kelly, of ophthalmologists in if sense the you and drugs have improve. dry because Schirmer of the fact Schirmer slight symptoms eye that hand, On an a indicator to activity tears, mentioned, for that have a test

Operator

BTIG. is of Thomas Shrader question next from Our

Sung Hong

for Sung Tom. is calling in This in

X like One XXX. have question kind of So, from I follow-up questions. earlier is a about

indications thoughts And So makes indications, to study? currently, multiple for partner you guys it XXXX III the bigger a question but sense then and second any whether have potentially which in to PVR. on Phase is for prioritize,

thinking sales for down potential sales force could Just eye you indication color with effect? the whether dry line, any potential force any overlap for a the provide there's about commercialization synergistic on and disease

Dr. Todd Brady

that small than companies orphan is bias are at better drugs. commercializing drugs mass-market general My

So, for disease and we're in Phase II work for Phase a certainly -- all Sjogren-Larsson prioritize testing, indications where, an past think to III is change testing, indications that the we progress Partnering us. always or a scenario would all minimal option ADX-XXX, able diseases I smaller clinical company, as into clinical and syndrome. is

more any think drugs, events or to were is there that key significant think are considerable I so clinically And adverse identify, related a patients that immunological R&D and we I XX message demand for across drugs new than tested, specialty safe. from Day was drug. were to unable

considerable my we've which Of entertain think indication would alcoholic for as consider I cough. toxicity, do is partnering that development discussions look would ADX-XXX, have we'll or as to ones as indications. ethanol I a mentioned gateway And to belief is company, ASH, business a we mass-market hepatitis, chronic So, opportunity. around well the

we I apply there of are more Project bit think call brothers many to what indications sisters drug spent is many, little which about talking R&D We X, would time a a at that the Day of and ADX-XXX. And I belief, mentioned be previously, in be would new diseases. look for larger to molecules I candidates our those as newer unparalleled, designed for modulators. in engine discovery to tested the would RASP partnering. that, diseases generate is

Sung Hong

force dry provide sales force potentially? on the required Great. overlap with and color could eye you just the effect, the there's And XXXX, then synergistic a any then, for just regarding disease if sales

Dr. Todd Brady

later. training overlap legal, cetera, though, Yes, you is, either office sales and back your et the would forth. the are physician the disease in pharmaceuticals for sales of launch but that standard compliance, reminder. Injectable need eye, not of is them different, though, that The for Typically, no. kinds of reimbursed the would I terms of typical the their access, purchase because force drugs for marketing not your towards access, may different. Back terms involves a only force surgeons get of quite ADX-XXXX dry or and the to expertise the of and also the surgeons ophthalmology considerable reimbursement, sales so is broadly. back front that are geared office, then emphasis eye retinal their eye a on and the whereas billing, populations in It are is process. sales sales force representative have efforts, outlook ophthalmology, have on say, thank of and yes, answer allergic so forces ADX-XXXX. front different office, the and typically typically practice, in drugs for in heavier buy-and-build, sales and towards terms of meaning conjunctivitis That geared more we

Operator

comes question next Partners. Global Cross Our from Matthew Alliance at

Matthew Cross

that review of done wanted equation majority fashion. then, kind contingent this I fronts, rationale comparator, still is in that of related prior dosing, as baseline after there, know TRANQUILITY. which to opposed on redness, handling handling that part assessed being to before in I they'll confirm the reminder guys or both in what in wanted role. Joshua on, two the more the on to just that I trials, the straight with fully relative points to wishes guess, both to looking in Schirmer's, a to so-called time wanted of was the handling you're get TRANQUILITY-X a just given to exact and you as in a are be I to to studies. looking these you necessarily for you've doses if wanted the have new this was, that split enrolled. endpoints at bit expected strict, TRANQULITY-X And prior the whether at and know Schirmer's. of saw for fourth for on I But I particular, drill post to on should the And the not extent, significant be the that, successful backup analysis given Best these dose the little mirrored, X in down of in all some to primary basically, that

Dr. Todd Brady

as your interesting the I've nuances. points some understood companies Single Well, is, are time to usual, and power. pick They never same, the you've points. turns single riskier. diminish questions Matt, It is why time statistical statistical both answer that raised out

have don't all You Never clinically relevant asked statistically did much or a Smith, you and day patient, clinically approach data, they're Mrs. powerful feel and throw on and XX, the before I to data. away a include Instead, more not is relevant. of how after? about the I care

of X fourth fourth absolutely and right, assessing the in Schirmer both change so, fourth test, for the particular, the dose. fourth point. we The more test dose, than before activity with which incorporated And adds a increases from of And in before one not measuring redness the model. in both after those improvement chamber, things, The post baseline albeit statistical and sort the slope fourth include you're after doses, we're approximately eye the first time the the data -- dose so have the with dose activity is accounts with and can In or or acute the power XX may the may XX endpoints of Both the only the present accounts be that model, for model. dose Schirmer points are in X is, different we're time redness baseline. are time dry relevant. X generally, assessed, to which so of all time that be of clinically points We assessment with points chamber. over

is, getting slope one drug be you higher the but approach drug. the worse patient chamber, As would would a than way expect That is worse, than eye dry to think you vehicles a to getting expect is on vehicle? generally, that in on So, I've slope. patient about on statistical just if you're such a mentioned, is with which

that of I clinically think all very is relevant.

As health we are patients care providers, do how concerned over time. with

approach do TRANQUILITY-X answer time We are with patients reasons, a TRANQUILITY-X statistical be mirrored and we will at analyze multiple studies your The And clinical time. both for statistical the for not is relevance concerned to for how thus, yes. backup about absolutely, be particular question the mirrored, points.

the absolutely We statistical to change about are plan. intending nothing

that is, is In are That a some The back the Schirmer is, weeks as crossover chamber TRANQUILITY, those and largely trial patients versa, chamber. count patient of crossed come is fact, may course, studies the sequence test a then and or over. the of doesn't and vice except later drug the randomized. conduct The same have same. vehicle trial get

Matthew Cross

it. Got

helpful there, it. on sneak quick in can one study. you appreciate confirmation, I mentioned Todd; Really Okay. I insight know that initiated several fronts if And INVIGORATE-X, I for you'd that already

effective variability. on initiated, guess, that terms patients a XXXX really still planning bulk in given intention those to the of patients I study, seasonality So, just data of avoid wanted enrolling in to but know kind Is or for just I your readout? to confirm, enroll winter an of

Dr. Todd Brady

allergy-free the conjunctivitis, during dry learning pollen about certain that over again, of a year seasonality enroll matters. the summer, data not atmosphere during X of a the commercial winters, with matters But front And that X yes, fall. enrollment. have for good conjunctivitis, it for the have we're because to is allergic year. pollen. you is perhaps in thus, run your for which spring thus, of the trial expect and or is parts only the INVIGORATE-X such in allergic and a have answer the to we we Unfortunately, clinical Enrollment question because operations, probably allergic of do always we in other eye allergy we to It chamber, conjunctivitis, are enrollment middle but during confounded. begun cannot and of terms compounds in the pollen What of the trial, have exposure whether eye, not results is, the in disease robust, or say, has about in definitely to we enroll out pollen, clinical parts demand be coming cannot sign, pollen the maybe been next The year, therapy. the seasons, terms in atmosphere, the

Operator

question Trading. [Operator from Our Catherine Novack is of Jones Instructions] next

Catherine Novack

on additional XXX studies, particular, well just of reproxalap as in trials I couple R&D One, and the studies? to those the as expecting the ones. for cost ongoing a be reproxalap I ask, spend running with we for of wanted quick studies, for year, have how the should much

Joshua Reed

broadly, all give as the XXXX, disease RASP in platform, With in with to our in well Yes. our and question, the TRANQUILITY-X planned particularly XXXX the guidance should advancing spend, change ADX-XXX Catherine. SLS, in trials chronic R&D, from spend. minimal INVIGORATE-X broad you activity ethanol Thanks for retina programs development R&D toxicity, as cough, I'll regarding to to our levels. our expect to increase compared some

Catherine Novack

get that, Got else of sense analytical look to be plans? locked? that addition TRANQUILITY it's as the to trying then, just a And expect a to period, when to we given dosing the data, And short needs is forward to it. in already what database wondering completed

Dr. Todd Brady

Cathy. It for is get frequently. question, Thanks that we one the

Let think me explain clinical at I back take and analyze sponsors a just step most how trials. least

The is to I many complicated are whether was specific visit there you are the itself, data patient's each i.e., because endpoint, close data visit, quality -- the which QC'd. point it's out, last to for data the patient's discussing response in there of as process as so a Matt's of step which -- following in control completion very is There endpoints, first is last last the enrollment the first for particular are trial our question. analyzing

I process happy However, believe complete. is that nearly that report that I'm to

the been changed queries the database Following sponsor between quality that and cannot CRO be is have the database clinical further, and completion, the satisfied. locked, meaning the control sites that the any all

any codes. is statistical the firm. knows is randomization QC case and whether statistical statistical drug firm statistical the process that to what person sent statistical time the that vehicle. or is follows patient only statistical firm. is yet randomization firm, After at process has results. of the there what that who one only released at statistical is involves then, the patient There's an that has process sponsor that, occurred at the within aware a the which made on the following data then a QC in of are TRANQUILITY-X, firm, initial locking on is, the the analysis. a is test that what is is, generally, that means codes group only And -- one not which firm a article to the The process a database, the applied the then Following third-party QC of And database

answer, lock. lengthy when investors think in you for we've and in that for how And completed I are trial important analyzed. me but are nutshell, exactly we I the understand forgive a that process, sense a data given is pre-database hope what So, where a happens it's it's which to of

Operator

Hong question Esther at is Berenberg. from Our next

Elaine Kim

we convenience to to the is Elaine if for were or enough with or ask, growing is, be is with This on compete you gotten feedback just any as payers? And that itself getting. of Kim have ADX-XXXX injection a formulation a methotrexate wanted the methotrexate, follow-up specific conversations with wondering of We Esther. would KOLs support

Dr. Todd Brady

time questions for is The a XXXX. discuss last an that more your absolute I about. It's more Thanks topic focusing wish and payers question from on about we feedback had yes. to answer to

update year. convenience on in not discussing payers, this plans near the is ADX-XXXX, second believe product The intend we but and the we a been with for XXXX, have half GMP thing. only of NDA reproxalap submission, to could We regulatory of one which NDA submission be plans, particularly

injected patients' is think product Today, safety patients patients the I eyes, of with save or used. vitreoretinopathy be before proliferative of has methotrexate a lymphoma, another. methotrexate intravenous formulation in to the ocular GMP with is

open. -- So, certain the solution syringe, vial to allows of up and drawn enucleation process of is infection The your A inner inject is eye. introduction removal eye, problem -- an injecting that then an amount There is, is called a when the which endotheliitis, of of occasionally is which intravenous is into that condition the syringe the of cracked contaminants, potentially into the that methotrexate with eye used for that that it treatment. is a eye for serious. you're requires is

treatment which that of because methotrexate trial GUARD is lymphoma. care is ocular already interesting is III is use standard interesting, serious It's likely the which more enroll. the Oh, very your appreciate difficult to PVR, methotrexate compounded also consequences growing of of What's for -- made Phase is, our contamination, occur that in product. use for had more the non-GMP I also methotrexate about you of with product; the about these So question obviously, days. to asked

randomized As sites randomize clinical convince was is active surgeons investigators you of recall, patients, difficult either the trial, receive a and technically PVR. or standard because care. is that was the belief It patients GUARD of ongoing which where nothing, to to or our subjects, to of methotrexate for randomized trial nothing methotrexate to were

a think which PVR, surge continued the consider use good in and see describe to news. I that posters treat to papers manuscripts I we've methotrexate number and of the of

PVR product, much treat I've for I product the given if discussed. use than that retinal rather reasons the compounded choice, surgeons that GMP would most a think a already

question. for your thanks So,

Operator

question from Laidlaw Capital. next Jen Yale is Our from

Yale Jen

you, for Best luck Josh.

quick the ones design. study two here, both about Just

of the In Schirmer's, study, report terms have that the as what positive? the data, And then and the will X-day the might the crossover a even I study size as time what's chamber TRANQUILITY-X follow-up. of you well be rough [is]

Dr. Todd Brady

the ongoing read I chamber, submission in with changes Schirmer are symptoms are to we a to trials might the not we exact designed But have trials, a in really reiterating out The patient approximately completed randomization. in trial. statistically prepared at because the saw using that The in it technique, the subjects. we're this that's regarding significant predict NDA are group least for we timing hundreds roughly trial. within patient-to-patient conjunctivitis. makes crossover timing, [Technical highly trial trials from designed [Technical crossover patients might we those designed parallel is with is Difficulty] to year. is I drug and variability. we allergy what saw trial to eliminates allergy In XX What Schirmer uncomfortable. have crossover Difficulty] to just or the would numbers I believe is And which are crossover thus, in [Technical equivalent and TRANQUILITY, remember, signs so because standard sense that's so The you and trial, uncomfortable trials mimic XXX why our a X:X doing XXX think Difficulty] of the crossover compare about different midyear and to is think again, that which vehicle approximate crossover patients, allergic study in to expect we're subjects subjects

Yale Jen

That's Great. question one And more very here Okay. is for helpful. XXX.

about think you cough you Could as started design give description studies? each for brief study already toxicity, us You of those the mentioned I ethanol and a chronic of well.

Dr. Todd Brady

Day. Sure, enough, Both interestingly trials. R&D of at reviewed Yale. our those trials, are Absolutely. of that We had some crossover

That's ethanol? XX patient the trials or of type does you both tell, about those about of numbers does from does the And the in in or reasons discussed. that, As trials, of to especially we trials, feel patient coughing? have is, talking the How That Phase IIa just crossover ocular feel so are or for are designs eliminate to when so. are fans feel clinical after consuming subject-to-subject generally those why XX different you're person crossover crossover patient is important person, range consistent That how variability. can we're big I Phase How the about they terms symptoms. discomfort? subjects is, his patient of which her with II

Yale Jen

And Phase lastly, -- of on a Phase endpoint each the What the the follow-up of maybe might those II this. Okay. be studies just II? for for

Dr. Todd Brady

Right. We're symptoms. in also signs big believers and

sign toward moved drugs, typically, assessing of the over has think FDA shift a and symptom calculus agree past in for the and thinking. several activity decades, I the we with that

markers liver flushing, then liver, as And have case of impression global involve of both that to cough hours. to the can of tests. That life, objectively same emesis, and chronic proprioception that a dizziness, the signs such coughs is impression of true for so with acetaldehyde of levels, for sign attached so measure The of these, signs. function to number whole condition, The in symptoms, endpoint inflammation global chronic ethanol patient's be device are symptoms other of XX bunch over that ethanol, have RASP regard typical the that is nausea, cough. and the on, quality tests, vomiting, FDA ethanol each of with case we the levels be seems for Alongside So, standard other and disease, cetera. chest. subjective measured improvement, each a we'll exposure of symptoms, et in

Yale Jen

this or is a in placebo is study, arm? And single there this involved a just

Dr. Todd Brady

the or either is them and or and placebo of should controlled, and so placebo -- vehicle I Both then drug drug say, and placebo, are drug. crossover vehicle, then

Yale Jen

And Great. Okay. on progress. congrats the

Operator

the to Dr. will I We the questions Brady. have no on so call, further back floor hand

Dr. Todd Brady

all about as you posted joining regarding us thank today. for And always, you we're keeping and updates events. excited Well, future our

Operator

concludes you joining. conference much all for call. This today's Thank very

disconnect now may your lines. You

Aldeyra Therapeutics (ALDX) 5 May 222022 Q1 Earnings call transcript