Aldeyra Therapeutics (ALDX) 28 Oct 212021 Q3 Earnings call transcript

Company Profile

Participants

Joshua Reed	Chief Financial Officer
Todd Brady	President & Chief Executive Officer
Tom Shrader	BTIG
Justin Kim	Oppenheimer & Company
Yigal Nochomovitz	Citigroup
Marc Goodman	SVB Leerink
Kelly Shi	Jefferies
Edwin Zhang	H.C. Wainwright
Prakhar Agrawal	JonesTrading
Esther Hong	Berenberg
Yale Jen	Laidlaw & Company

Call transcript

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Aldeyra Therapeutics Third Quarter 2021 Financial Results Conference Call. [Operator Instructions] I would now like to hand over the conference to the company's Chief Financial Officer, Mr. Joshua Reed. Please go ahead, sir.

Joshua Reed

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

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

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

this morning company's materially to Brady. to issued will and Dr. forward-looking turn I over in described with the factors in Additional detail the results information cause filings could press from SEC. greater concerning differ our now that call release are statements the our

Todd Brady

This progress continue the you, the of ocular of unmet approaches excited strive immunological I’m patients we as share to to and therapeutic our made for improve medical you novel important Thank lives diseases development to Joshua. and with morning with needs. significant systemic we’ve

by ocular Let me on begin anterior you updating our segment programs.

of quarter, that the TRANQUILITY TRANQUILITY-X the clinical we redness, line arguably dry matters from of disease these disease. ocular sign is is This trials patients. of reproxalap to eye report expect the primary The which results dry top eye endpoint in trials objective only and

Schirmer's Secondary tear eye endpoints levels, are RASP symptoms. test, and dry

Additionally, the FDA trial position early we application reproxalap timing of clinical disease. and including a consistent file enrollment drug a the in eye optimize II tear guidance, dry parallel months next the double-masked Phase clinical disease. results trial has purpose prior of eye Phase or Pending for to and be measure process to of discussions safety new expect year NDA ongoing our reproxalap collection is RASP. multicenter completed with a group, to XX with The the of vehicle-controlled randomized II trial in dry to in

for In to of addition, expect provide be and able the discussions allergic for end FDA NDA conjunctivitis, an year. we regarding this NDA remain requirements in update to by with reproxalap the

and of PubMed. is of of a experience eyedrop available reproxalap open reproxalap and Clinical safety clinical and Journal lifitegrast the journals Ocular versus conjunctivitis. with on Most eye eye in peer lifitegrast trial several evaluating reviewed allergic During two have in dry reported articles access results dry efficacy the reproxalap profile patients year, disease of Post-Acute published of the entitled highlighting the disease. Ophthalmology the Comparison The formulations subjective paper recently, Tolerability and

approximately tolerability been we has X,XXX Phase retina in this primary of vitreoretinal people designation endpoint end orphan initiate an indications do XX,XXX is eye and of proliferative United trial will our to and States, PVR ADX-XXXX safety drug patients individuals worldwide. X announced ADX-XXXX, the rare affects by to and that or affect diseases lymphoma. genetic group trial granted plan you XXX,XXX our know pigmentosa of pigmentosa, retina. on quarter, for track retinitis the pigmentosa, primary estimated The to many year. vitreoretinopathy the of in Turning programs, in so ADX-XXXX. Last with be Retinitis clinical II and remain the to distinct Retinitis a as clinical we that three a of of

retinal Secondary detachment visual is retinal surgery. of a and sensitivity, PVR the threatening condition sight adapted sensitivity, and cause retinal dark of We failure central acuity, endpoints include retinal morphology. leading on next the III enrollment ongoing trial expect of X at year for our to conclude from GUARD year. remain of GUARD end this And Part PVR. track results in Phase we

to We be mediated treat rare, approved no continue immune potential ADX-XXXX about have platform today that retinal broad therapies. to the excited diseases of currently and the ADX-XXXX

possibility to asthma, COVID-XX where first We've ADX-XXX report that therapeutic XXXX, and target our results to or either approach evaluate in based quarter XXXX. orally of in program, toxicity. ADX-XXX may mediate on available to a inadequately and ADX-XXX current mediated of drugs represents first-in-class systems in is psoriasis diseases toxic. or currently effective treated where proof-of-concept from clinical disease fourth to It expanding treatment single many continued Turning the pathology we remain clinical potential the for that RASP RASP with II inhibitor. testing also can systemic of the other the is therapy track for of lead indications our are immune Phase quarter

this update later third back our call turn to on to our Joshua expect review With the progress over to financial year. that, quarter results. We you I'll

Joshua Reed

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

third million $X.X Research September and $X.X consulting results. XX, clinical administrative development the $X.X administrative increase XXXX. for expenses. ended our due primarily increases expenditures of million in by development compared of in September with XXXX, and the is XX, related $XXX,XXX The an ended for increase loss XXXX with partially share for The $XX.X of Turning million of XX, third was or research of including million, The or million per in the with $XX.X miscellaneous quarter share loss XXXX. ended quarter and is million the compensation period and were and for expenses compared primarily XXXX for costs, stock-based XX, offset increase XXXX. costs, activities. million to the compared XXXX, $X.X September related per net same General September quarter quarter decreases expenses were now $X.X quarter personnel $X.XX ended the manufacturing to $X.XX for quarter a to net

Please Eyecelerator XXXX featured next our Events for Todd conferences and virtually month's XX, the at details. XXXX, and and of of American at investor Ophthalmology's presenting Annual hosted November event will participating be by I calendar, in will Todd Orleans. ahead check Looking AAO Presentations be upcoming Berenberg of in a BTIG. New at Academy section our Meeting Jefferies, On website

at one-on-one, email please conferences to schedule any our attending team the a would of like and aldx@investorrelations.com. Relations you're Investor If

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

Todd Brady

Thank you, Joshua.

make to treatments ocular diseases. systemic in developing meaningful for safe continue effective progress We and and

innovative our inflammatory therapies your about anterior beyond first happy we In believe by significant development Operator? value medicines create that conditions with developing of commercial company. representing that committed being we're diseases addition And opportunities segment, applications a the therapeutic milestones today. to take Joshua We're array inflammatory questions. the to systemic diseases, treatment ahead. for have be surface we sufficiently retinal clinical standard With controlled our current the that, line of by near-term and to inflammatory and will versus several broad expanding excited that a are reproxalap percentage quarter, to I'll high a for busy care we of And present approaches as are not exciting not significant adequately anterior are quarters patients. for treated for diseases potential

Operator

first line Your the Instructions] [Operator from from is BTIG. Shrader of Tom question

now open. is line Your

Tom Shrader

your existing morning. the front. about some good a thought question short-term alliance commercial own? company. set had that on an on something Is seen the that? companies, I Or up you whatever you Thank you We've to commercialization think easy space? that's a likely in questions. do with companies use for to Hi, Have product you taking do, young you're do first this

Joshua Reed

So Tom. thanks for the question,

eye. dry profile existing onset is Let reproxalap's saying of data extremely products attractive. me the off start This symptom prospects and activity, makes shows broad that by unmatched improvement BD early in our commercial effect and on redness by

NDA this if line course, the only on The of clinical is the and building it approved, Of success is potential our us makes And anticipated our our could it submission. infrastructure support a commercial that for attractive own. strategic top partners. is product trials

extremely a But at have to for to short-term one options that's available us, to lots have again, easy available up. organization lots basis us, of we the options us. set to something mentioned, you we including reproxalap's potential, different So that commercial with is using a least commercialize of on

Tom Shrader

flip eyes are FDA. ask test you way redness? Does And thought an like the It's important the patients labels than still so the fundamentally We've on I enormous do Or loophole. seen does a back The Just the if Schirmer, of because different benefiting, think Schirmer almost make Schirmer redness, negotiation? is, side hit is conventional your than different very to sense? unrelated you that but the can a Okay. follow-up. if you'd be the power clearly it's generic in of eyedrops. -- but label not how

Todd Brady

products disease. Restasis that ago, as Hi, Todd. still it are there the for time eye on focused Schirmer's with objective test Thanks the I that with resonate question. It's seems so because question beginning for many dry Tom. Good that morning. years

that major signs is As one mentioned can And my red of about eye about have ocular is or care why I one redness, wants is to disease. a That think by sign I patients dry eye. and that don't prepared care obvious a redness, patients which signs this dry objective of assessed eye staff physicians disease. it's in exception, morning, that with no be comments

any our way think in don't detriment. ocular redness in is I Now, a label having

In ocular optometrists potentially, a fact, commercial available, that is it diminishes providers, that significant there that a and advantage physicians, health eyes whitens see for patients their I to redness. think drug is care

today I very think treatment and market relative advantage drugs of to powerful the chronic disease. on for dry eye commercially it's very, tremendous a

all for secondary my in end, prepared that described reasons We current I comments continue eye dry focused test I on morning. ocular we're about Schirmer's redness trials in and endpoint our a this be the the Schirmer's. asked is to But that described. just disease

Tom Shrader

thank you. Okay,

Operator

is Company. next of the Kim Your line Oppenheimer Justin from question from &

Your line is now open.

Justin Kim

taking dry Hi, good couple thanks Maybe question. eye. for and morning on a the all just

dry we comment With and results those eye first And II data can little in available bit the being disclosed as a might III anticipated about the can be team to program? forming available, study? the what from think Phase how Phase the

Todd Brady

Right.

that. signal. Justin, my and thanks excellent eye it's to from Phase in for prepared optimize The mentioned to the RASP that question patients. designed able comments more collection so trial dry that designed I In of is peers we're particular, the optimize II collect tears to

the this And patient of of is or that is two is a correct, first The trial complete of the from Phase Phase be can the II the tears subjects. trials. trial is than smaller in results is trial Phase trials subjects. challenging will Phase as population enrollment II trials. simply complete Each announced imagine, will roughly morning XXX II The collecting your because is we've II the a available tears TRANQUILITY you assumption I TRANQUILITY XXX is for the and trial half lack process. think size that approximately TRANQUILITY As trial

pivotal. the TRANQUILITY the think In to critical filing. II the we'll trials. not RASP also is it's data trial optimize completion that is Phase in the able to for NDA I the trial itself, to path from II It be reasonable assume not of order assess Phase

the depending be those trial, data. have could on we'll But the results of that things. just to think see I both

announced Phase our data have the data the Otherwise, we'll think a from I RASP with concerns question materiality once in releases. that so the to in trial answer forth, that have whether that we is data be we a release I possession. other and the conjunction data think trial, need data could II

Justin Kim

it assume sort of of the of of initiation Understood. less study sizes? And given sort those is that of of studies about the the of enrolled maybe you the to point TRANQUILITY-X the initiations had studies, Understood. and on least that mentioned and the at sort timing TRANQUILITY sizes of is half, fair little the considering and the timing at half least than a sort

Todd Brady

at TRANQUILITY to on option those its as database on the typically TRANQUILITY you enrollment do TRANQUILITY completed. we in prior based comment those until trial dates think That don't the lock II that the if of powered, Phase not is assume that the is expand of data Well, I been II enrollment trials. to sufficiently the is have well on trials fair has either from if of from either needed. Phase is, to of the it's the least, trial trials, expanding the we suggests trial One way given option enrollment, mentioned, either data towards trials. completion, start the TRANQUILITY-X not of

don't quite the data. complete Phase what enrollment sense, is until either So we in have II in know trial a we TRANQUILITY

Justin Kim

helpful. Okay, question answers great. the and Very for Thanks .

Todd Brady

Thanks, Justin.

Operator

of question from the Your Nochomovitz next is Citigroup. line from Yigal

is open. line Your now

Yigal Nochomovitz

RASP and you the Thank Todd II in questions. Hi, II If for eye? measurement for is tear could heading secondary -- the RASP additional goal TRANQUILITY Josh. wasn't a were Phase you why bit detail this tear is could endpoint? explain reproxalap more just the the levels clarify for Phase levels Todd, purpose in the rasp optimize levels, dry taking of you a just is to trials, completed this into before

Todd Brady

Good morning, Yigal.

a think question I well. that's good as

dry interested by as FDA we're the was by of eye year. last sign designated a disease begin me RASP Let RASP. why explaining in

cohort fact this we're redness a addition in also However, I data why redness in mentioned Tom's we is my think to January morning, that focusing was the demonstrate the running in to announced in sign And of response of year earlier in as providers allergic and question that very the conjunctivitis. TRANQUILITY to relevant ocular And to more on that's we redness positive continue this redness positive. data patients.

include ability also it's in or think tears modulating patients. we that drug to the I commercially And of diminish However, the differentiating. we're RASP pharmacology interested showing in of potential section our data can why so RASP mechanisms that's and There do that. eyedrop RASP ways which and of mechanisms II two I primary believe first to we collect is target Phase clinical the The reproxalap would modulation demonstrate we trial target be a by the in trial. ever the tears. are altered to label,

need The first lake capillary small approximately can after We extracted dry for to X minutes. inserted glass there of XX with microliters analysis. tear have that's that of fluid the X eye surface the of is in the retracted, disease lid a is many remain don't are patients lower RASP be fluid. microliters for a capillary that about in remarkably, And or eye near

your typical reference, is XX for microliters. Just eyedrop

eye fluid of amazingly, your dry minutes strip and or be analyzed. lid place the of as eyedropper the microliters. other an a can about then to volume so, hand II We've Schirmer a ran of method tear up centrifuge as lake spawned extraction in removed, retraction. Schirmer is test. strip assess drop take then can following remain tears, home, the into of enough the in which trial. is lower into -- capillary a patients strip eye on extract a for RASP, we you be which is you XX if in around inserted about many order And test, XX down at then the our trials also the the you the of the in And change fluid know, Phase paper, strip. the palm to some that's tear simply that, can So at you is why switched they you the whipped small drop The The look The drop don't that processes. have

TRANQUILITY with process prior Yigal? timing and be that and redness out, to a then response levels. which the data. to Does to pattern then that have that our data, the as II evolve an trials and measure forth. will different that a after for I tears you statisticians timing it's in Phase have redness describing clinical data January, RASP to using point somewhat to other to symptoms is we'll running forth. was that analyze the announced transferred is the tears think shipped Subsequently, RASP RASP results and our analyzed reasonable and question, clinical may data from to reason separately. laboratory. Justin's the are is here The ELISA, announced could the in the of third-party of As our assume so RASP similar that so answer data the I And we are results. the our and data the clinical symptoms your And announced The we Those back them we first data clinical cohort the come a question,

Yigal Nochomovitz

And you. for just thank Yes, one I had Josh.

in mentioned about just if you of release specific the bit support be cash I’m to what have the reproxalap. that think encompasses? could and that initial commercialization a I initial you wondering of you press definition more

Joshua Reed

that is Thanks, another what referring to home think Yigal. there and what XXXX. Thanks. -- factor out I'm is office Essentially the out runway to of our there about to building

the I support enough have product commercialization be cash -- will So that launch. to we an signal it's that effort, important not we'll entire well think after

Yigal Nochomovitz

Thank it. Got you.

Operator

Your SVB from of is Leerink. from next the question line Goodman Marc

Your line open. is now

Marc Goodman

from wondering being that Thanks. what's checked boxes walk the data. you all about TRANQUILITY-X, was there so I the when through us just towards get file. you morning. could to Talk good Yes, left, actually us if you TRANQUILITY-X, understand we

Todd Brady

filing. NDA Mark. to to prior the comment Happy morning. on Good boxes to check Hi, remaining

symptom. our submission eye Those believe pivotal week symptom that we've submission. are we our this that remaining RASP, dryness eye focused FDA as the morning, trials we've sign for the though also are NDA The requirements. on our and data in trials XX discussed symptoms the sign deck dry and with test. TRANQUILITY-X disease. trials in for Schirmer's were NDA as particularly and redness, We prominently highlighted two X And completed requires requirements corporate ocular know, you As is assessing using signs

safety NDA the with must the is part there requirements package. generally, our to efficacy consistent requirements addition that submissions a be of safety submitted In NDA for submission, trial

disease. reproxalap running in use the said prepared are support for this I morning, that terms dry will trial safety we gating and currently eye months safety the submission As be trial for factor to the continue XX-month my believe to NDA XX us comments chronic a of I timing. in

In addition, requirements for with and believe of what to requirements. basic I rounds NDA. control the regard And there the are submission. chemistry need position manufacturing C&C we to NDA are our that in we I think that file components out excellent

Marc Goodman

done, So run that's into when And filing that's as soon safety the you're gating going is thinking to early year that the that's occur. next XX-month issue. and the as

So the that will means that's gating year whatever be issue? early next

Todd Brady

safety FDA will to remaining patients be gating factors the submission. months must through FDA. months data At submission, The one X drug that for will for months is requires the of that the X and update from be And of the XXX-day treated NDA of the that I timing trial believe submitted -- XX be the XXX after NDA submission. X

safety time is XXX-day update, approximately required, the submission, the by remaining of so complete. data that NDA X be data or months so of the at safety would So

Marc Goodman

fourth noticing year always in could your on basically quarter any the mind? in could the saying quarter. impact that? of anything also it's Has year in come next by Or come been end the you're or the like it's there XXX, around And been early first the this enrollment is that COVID data

Todd Brady

the early be of the results always towards the end certainly year. of the We've latter. could available year, next trials this that It's thought

we being some treat data do these expect to concerned impact the new trial. We seen understandably trials, trial The are in have to also to reason able or has interest per our where the about our Nonetheless, drugs impact on enrolling had and presenting given on antibodies trials COVID there therapeutic disease COVID diminished asthma recent clinics environment COVID vaccinations of COVID. or respiratory particularly clinical COVID that We’ve are guidance. patients boosters announce trial be itself. to a and and in hospital

trials. indicate includes be aggregate. the Phase RASP are can these those to ADX-XXX to the expect designed all cytokine results, which clinical three listeners indicate with rather signals are of a They proof-of-concept that levels particularly early of ADX-XXX trials designed, clinical clinical trials also evaluate remind nor to year. We the they in levels, we next on and starting as are II trials, Phase trials run the To the are powered pharmacodynamic call, announce not potential future IIb statistically

Marc Goodman

Thanks.

Todd Brady

Thanks, Marc.

Operator

is Shi question next Kelly Jefferies. from Your of from line the

open. now Your line is

Kelly Shi

[indiscernible] you regarding Thank TRANQUILITY The you redness I that conjunctivitis what's of Thank -- Phase scores two was that the taking for and approximately of error patients. error In [ph] expectation of were since consistent were is one across II here each falls of Phase remarkable, the shed number have What III questions. could [indiscernible] also standard question standard are in Phase to [indiscernible] trial Phase And you questions from .XX mentioned standard III. my a like going new Phase run-in [ph] trials? arm. units the endpoints the error cohort? And outcome error see for design. III some stats in trial, II shed of of you. there, for first new standard INVIGORATE the redness your observation light your TRANQUILITY redness the ocular is two relevant [indiscernible]

Todd Brady

the for I at and am. math thanks Kelly, better you're questions than

dry both ahead disease So are chambers. forgive for -- TRANQUILITY allergy eye trials for trials Both eye INVIGORATE allergy trial, time the trial. example somewhat trial The dry in than and in in answers. different the are of the me simplistic

allergen populations chamber. low for humidity to However, with air different but patient and trials The the the with chamber are trials related, allergy eye the reasons. in obviously, no dry obvious in are the are

are there is the the patient across allergy are trials the What and I think chamber dry chamber populations there in between saying overlap but trials, disease. that and eye is some important conjunctivitis XX% there I'm dry a also eye approximately some differences. similarities allergic

Another trials which differences you that trials, is diminish standard the slightly important That the can difference These group intra differences as errors statistically reason. standard be patient the is controlled. error. so allergy be were with And will crossover trials. for that the not intra parallel dry would are are controlled. trials, higher to not case eye I that the chamber expect patient know

However, data, without don't We powering assess in the know. TRANQUILITY did the trials having TRANQUILITY cohort. we the run-in using the

described previously, point we the As the delta XX% run-in given the believe that at run-in was this in we've ocular TRANQUILITY are and cohort cohort redness errors. that trials for evidenced based the approximately on the standard powered

II I TRANQUILITY, think patients to power XX% XXX what patients us approximately the standard that RASP use I to error delta said the last regarding just run-in powered, trial that Phase TRANQUILITY of future that use observed possible the the and deviations arm of or inform your it part in and was Kelly question using XXX cohort. is on the TRANQUILITY. we I the particularly the to per or trials of resonate conduct to standard knowing back are

design. will previously receive TRANQUILITY of by is Phase that One that If to or data is sufficiently is that TRANQUILITY. that the that I've the and things we of the change enrollment numbers II the ability today powered, in we not mentioned suggests have

to ability sequenced TRANQUILITY-X purposefully Phase trials make needed. each powering that trial and II and changes TRANQUILITY-X, if we between have have so the of We the will those

if details all I forgive about you questions, mathematical haven't think Kelly, the but were me covered your I previously. that answers asking

Kelly Shi

It in was model Thank super helpful. also for III you one. estimate run-in a is quick substantial Should a the TRANQUILITY based stats a have I how the wonder number, design should Phase very If for I may change similar expect cohort the [Indiscernible] data? covariance applied I'm covariance? the I [ph] much. for like trials. analysis the III on Phase I on very

Todd Brady

I within time XX of is because in statistical am redness a TRANQUILITY each symptoms which points points. assessed Generally, on saying subject, fan repeated The for to at fact ANOVA for subject are measures, differently and are that in is because the to accounted error those of assessment that time that way assessed. believe there adjusting repeated different correlation the Those of are fancy referred covariance And the there you MRM, measures during between values. matrix a those time the chamber, forth ocular a Right. is big each techniques points. I for is method measures so are allow which standard based statistically multiple as are COVA XX different of and refer repeated.

Time minutes to it's is that that used attempts fact, In a the minutes. same points. points a what adjust time matrix. there amongst have subject, makes described. for. relationship time particular clear exactly That XX is minutes sense matrix reason that a fairly is, time probably I are very within is mathematically X typically -- clinical adjacent correlation That that similar related covariance time or covariance correlated. to XX adjacent We is covariance matrix fairly the just to matrix matrices across trials the for And

it think between correlation model. you repeated exact have time is I Perhaps the the We of fairly haven't understanding see statistical now, disclosed think trials.gov. good how and about we posted clinical on when you'll one for the SAP But a points. measures day

Kelly Shi

Todd. you Thank thorough for the answers. Thanks,

Todd Brady

Kelly. Thanks,

Operator

Your is next Wainwright. Edwin question from the from line of Zhang H.C.

now is line open. Your

Edwin Zhang

briefly And we Hi. new going trial question. Phase to from Thanks trial trial? my are improvement lastly, Can this you the about ADX-XXXX design talk endpoint? see of What trial retinitis II question data the to this what should Thank efficacy you. A look on pigmentosa. of and at some for expect for taking we the next year?

Todd Brady

regimens. an dosing as assess going endpoint are will we We're able it process has this expect a is will this design getting because running. trial safety different in primary that working morning. still this open-label be previously for year, be the I do mentioned mentioned, comments tested Edwin, on this up thanks, compound particular couple as And be prepared and question. Yes, of my the I been to ADX-XXXX Essentially, before. in I and to not

period. deck, I know, a couple or focus patients Edwin, obviously corporate this you looking or of approximately, also function pigmentosa we five morphology. retinal So, looking and dosing dosing X visual center but evaluation in cohorts in that retinal month the less we're our particular, can as We're trial. standard different be on, But retinitis that four a at and more we've secondary expect most cohort, a don't including, acuity, posted single at to see endpoints per all trials

Edwin Zhang

Great, thanks.

Operator

question Agrawal line the of Prakhar next JonesTrading. Your from is from

open. is now Your line

Prakhar Agrawal

questions. comment exposure NDA On the my good question safety morning, for Is around submission the of a by and clarity more end you conjunctivitis? a couple around efficacy confirm update Hi, then allergic conjunctivitis. follow-ups. My Could of is you have for data this the necessary your for how taking of thanks of is I first whether needed? year. indication And it getting on had allergic much in

Todd Brady

out -- trials have of two and trials Sure. Thanks, particular, with Prakhar. along III can No, Phase discussion endpoints. do that been lines. which though, a currently and significant efficacy secondary questions were of those completed primary should requirements. be detail are have FDA different. their The hit it safety more both In function bit under with those it to data. pointed the is not have statistically that The we into highly key I a go

this directly method manner. released ocular the case, case So announced, exposed XXXX surface was real earlier chamber ALLEVIATE conjunctival whereas with which year, is which allergen a In into pollen. The and to is INVIGORATE XXXX world. in a or pollen trial, of exposure this are I to that allergen more chamber subjects that an in challenge pollen aerosolized which is was the of that trial the in trial do is exposing believe a has

So that ongoing, currently discussion is the two III are the of requires that's with And as subject which trials agency, you different. Phase know, those and the discussions.

Prakhar Agrawal

And on it. backup secondly, you [ph] Got DI RASP early pipeline, previously about talked have stage innovation indications. testing for

months? questions. Just expect X Is something for the X any wondering my are there next in if to hear Thanks we there? can that to updates taking

Todd Brady

continuing Prakhar, inhibitors. We are committed, RASP to new develop the to

updating And discovering, extended of new some those in immunological preclinically we the We're potential very you positive on so point can testing my RASP variety to process along RASP new you morning, from lines optimizing, look and forward inhibitor next this analogues of patent we excitement As year. our on broadly Street in at forth. approaches tell of remain a disease. and the lives the with

Operator

line of from question is Esther from next Berenberg. Hong the Your

now Your is line open.

Esther Hong

morning. Good

So versus available Thanks. wanted eye in lifitegrast. if know I of dry you're to comparison regarding practicing publication disease getting physicians second, us the could the in? And reproxalap and remind you just that you the regarding fit reproxalap the feedback where therapies currently mentioned what's from findings might for then

Todd Brady

morning, Good Esther.

you we discussed eliminates data available the of leaders, paper compare or that appropriate. your minutes, that therapeutic opinion couple currently presented that that's formulations morning, for particularly access is late reproxalap which redness, commercial The of I on is the these getting in and that fence that two can feedback, all to minor. positive results the fence two advantage. from in dry key an is and key different we're chamber. days, paper, on particularly a is dry and difference is with know, only open quickly, advancing, attempt ocular of one of the reproxalap, ophthalmology whitening for reduces drug question see only you be a that eye ocular formulation the optometry be side surface. percentage call so in that the the disease according It's the that namely, is importance can idea that reference to us the the development PubMed. as formulations this currently think the earlier And I chronically Speaking of in to think reasons those to side available, But release of the eye as that on formulations the between used appears We within the delay a is also from either to excipient the that was tolerability similarly. the of theory January very works The novel including key drug the standard formulation. option increase stage between both perform we something We're we or

measure has is corporate of the in approval the at key is can The from formulation. assessed and better as symptom the score, considerably is the lifitegrast. one present, that a one You formulation symptoms thing the paper. is for also reproxalap see least in one deck the we was the data paper that but not tolerability paper symptom also which a it disease ocular based the eye trial say novel trial standard in evidenced of on tolerability, think versus in been XX-week our blurry are go I to a for a the head-to-head reproxalap say I'll activity discomfort discomfort, elements just can disturbances, represent vision, used paper. manuscript. comparison often activity, in how itself. both in three evidenced formulations could The I by are dry And of reproxalap acute in the is pivotal of of compared see other those And the a only That's lifitegrast lifitegrast. plagued score that Lifitegrast you one dry direct compound tested that taste is that directly would to relative performed same disease.

Esther Hong

it. Got Thanks.

Todd Brady

Thanks, Esther.

Operator

[Operator & Your of line Jen Laidlaw from Instructions] question the from next Company. Yale is

Your now open. line is

Yale Jen

not need the redness reach study is and necessary TRANQUILITY is correct? Todd, you Phase in for Schirmer, the or the not that might that the My main morning, for you first purpose just study size RASP, increase the for is potential questions. the whether if for thanks significance that reproxalap to trying the Good [indiscernible] the is study statistical mostly for for of confirm question but determining -- TRANQUILITY is II to the taking

Todd Brady

study RASP perform Good morning, Yale, the is the signal. the optimize II Phase the Well, and reason for to question. we thanks

trial, all it's able we trial data we available the of really trial, the inpatient II optimize when we clinical and And so for think exactly adjust prudent a and use Schirmer's will When test TRANQUILITY And the the initiated included adjust the ongoing timing I sequencing as the whatever, the powering trial endpoints, to use I power trial. and treatment that's and was collection with I the tear conduct of processes. and data trials. we've to be to clinical order current Phase think any from designed RASP when the RASP. forth, II redness, doing we're idea symptoms, to mentioned, wish. was company what of the to ongoing if included terms biotech Phase for in

advantage, the I the do though with But is powering the wish. And that trial any that if of think is we able II adjust from needed an added could exactly TRANQUILITY. what we're mentioned. we Phase to the endpoints data of take the for and that you

Yale Jen

that current we least moment, reasonably study the detecting should redness that assume in at well assumptions? But of the is at this for powered, the TRANQUILITY, does the assume terms size powered

Todd Brady

both made think that's powered TRANQUILITY an Yale, Phase is not trials are morning. redness. and II have excellent for that this I point, I the ocular the That

And one another to and Phase in II on While we latter by the slightly much optimize signal, with factor case, of different that case, group powered interested standard used endpoint powering this redness. the in RASP being deviations, used individual pooled XX% in conservative, you trial? The is in trial answer techniques. two those groups one the is in case. you Phase Phase XXX XXX approximately can the II was the use another of And how The we the the a obviously II reach for power mathematics, standard is deviations. subjects are of in was designed more we then based ocular ocular subjects redness. also And primary question well,

trials the So Phase XX III and reality, going we II I patients. and And should a run-in trial patients. be for again, adequately need believe II adjust powered power to the Phase power Phase and ocular there no then that The think the calculations, redness. both was is reflect XXX But the if then are forward. calculations and powering the cohort

mentioned, I it's biotech most any clinical data company think for to the fulsome ongoing power to take power recent adjust the As for or prudent and trial. I clinical

Yale Jen

a great. comprehensive two very XXXX. up question Maybe here. answer. That's the Actually Okay, one on

the have about endpoints the you thought your this? the consultants The first about with what RP? Phase might After with potential for for approval or one spoke be Have study, is you FDA RP. II

Todd Brady

should I just to inbound broadly I program a tremendously There up tremendous development Thanks we in, come and is so the data well about agency though, get be population different pivotal we're NDA those the have that the have We There remain that provide brought outset the functional RP well. and drugs least asking kudos able excited RP discussed the the medical their those and to and motivated see our in providers thoughts for unmet until the a a variety we'll in thrilled rare have be to in think with There's closer many initial for typically including we've received requests wishes pigmentosa. clarity conditions. with able the retinitis as for case I at submission RP, no for agency. studies, typically, and organizing for community. need. patients so more as we're some is lighting we're endpoints to patient extremely know on and the say data and and effectively, And discussions participate concern, pivotal for patient that retinitis and endpoints, for about pigmentosa. My clinical possibly that Edwin patients The forth. endpoints a agency. a at we And operate understanding is point. don't of as at discussions those generating to approved ability retinitis diseases, pigmentosa data, to with at discuss to needed retinal

Yale Jen

front? for a vitreoretinal on lymphoma. the XXXX. last also also of the that mentioned maybe recently potentially be used discussion that can Is lymphoma, drug in And this Any thoughts one in you terms

Todd Brady

agency NDA with ocular lymphoma. of well active XXXX. and cancers And as sense, is in primary is There literature There in survival and one as use and treat is treatment Lymphoma, the condition. is lymphoma the that the in literature, our in about able is terms both ingredient PBRL may for as a the to systemic often that submission those other those Yale. use considerable to mechanisms scientific or currently discussions the of eye is primary involve the on metastasized administration amount to ongoing, I occurs believe ocular scientific discussions a intra The the that serious for drug median brain. or is is methotrexate, of lymphoma, we which X the it literature be administration the the for are methotrexate challenge used years. of CNS

Yale Jen

Okay, congrats great. and Thanks a for progresses. all the lot

Todd Brady

the Yes, excellent questions. Thanks for thanks, Yale.

Operator

There are Brady over no further call Dr. questions. for closing hand to the I back comments. will

Todd Brady

morning. Thank you joining all this us for

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

Operator

attending. for that, concludes this with you call. today's Thank conference And

disconnect. You may now

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