ALDX - Earnings call transcript Q1 2019 | Aldeyra Therapeutics, Inc.

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Operator

Good morning and welcome to the Aldeyra Therapeutics First Quarter 2019 Financial Results and Corporate Update Conference Call. All participants will be in listen-only mode. [Operator Instructions]. After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions]. is event today’s note being recorded. Please like Reed, Chief now to turn Joshua to over conference Financial the I’d Officer. Please go ahead, sir.

Joshua Reed

call the Good welcome Therapeutics Joshua Aldeyra our and of is future morning, Reed, Chief me update. financial Executive Officer Dr. XXXX Financial regarding of am conference everyone. results performance events today Officer first and Aldeyra. quarter Therapeutics. to contains call conference And Aldeyra statements the future Aldeyra. to discuss Todd forward-looking With Chief I corporate of This Brady,

among and upon Forward-looking could or or statements available research, include today, assumed information sizing, potential those future statements statements other materially things. plans as position, to obligation opportunities industry update based results regarding These Aldeyra trends, projected expectations, and Aldeyra's results the possible of change. forward-looking business these are position, actual operations, differ financial company commercial circumstances and and competitive to statements. plans, statements and no assumes company's strategies from in events the market development and Future environment expenses, the growth

in financial information company's earlier quarter that could cause detail our forward-looking the the release results press Additional of results containing company's statements for are and concerning the this in XXXX greater differ morning materially issued described with SEC. to factors from the first filings

the to Aldeyra. Todd Dr. turn over Brady, Chief call like Brady? Dr. of to Executive and Now, Officer I would President

Todd Brady

initiation press which results it with our of today’s to of first encourage is with our off X a X information We you, trial release The in X Phase XXXX first in in ocular Thank corporate issued we concentrations in and of The the a in XXXX and late-stage to positive remarkable announced the Phase to is our dry anterior uveitis. from the eye press start RENEW important be results contains our completion Phase ALLEVIATE Phase noninfectious to trial results X trial topical represent disease dosing outlines the conjunctivitis. at of pipeline ALLEVIATE SOLACE considered adaptive March model we report Joshua. Today in primary for secondary allergic of in conjunction statistical announcement from were call. allergic drug provided as significance reproxalap and conjunctivitis review that trial. you quarter which a were financial results challenge vehicle release versus our endpoint achieved update. thrilled concentrations both the the tested and the that of key to a

with announced United short-term the some many can toxic, to design allergen announced of the dry of the an in trial previously patients we trial. part Phase the for symptom conjunctivitis were fluorescein of which staining for for the and and the severe relative use. vehicle trial, requirements million physicians As to score Phase second The in is onset reproxalap comprise that respectively, in results to treated in we’ve ocular environmental are exposure the ocular RENEW X.XXXX and the to XX is determine conditions the X.XXXX causing estimated adaptive we of the studies results Xb But methods nasal eye generally sub-optimally disease eye initiation patient corticosteroids trial, with a Phase therefore endpoint quality-of-life results conjunctivitis. allergic disease of methods submission treatment resort NDA and which April, the in subsequently confirm be the authorities and In the glaucoma ongoing discuss demonstrated RENEW antihistamines, development trial. Xb groups which the of and with broad be dry dryness from XXXX, co-primary of moderate disease. the diminishes that in to X values other will objective disclosed, clinical complete early are States tested of activity ALLEVIATE clinical to disturbing serious among remaining study is RENEW first we topical limited In RENEW. intend patients, to part cataracts P regulatory corticosteroids. region to persistently and Allergic development

dosing the assuming for completion part sample expect of the Following trial. remainder report first results support to the size we RENEW to further the of advancement the of testing, and endpoints regimen

X corticosteroids, in new SOLACE topical dry noninfectious or some topical available clinical announced cell chamber In in to trial anterior a for report corticosteroid are statistically The the demand. in Phase X The generally positive topical a later clinical toxicity the cells X alternative trial that is inflammatory serious was of vehicle which and that for to to the severe the disease rare to Phase endpoint reducing high XX count results and noninfectious chamber United in treated estimated Also, which SOLACE condition trial mentioned million of patients. with noninfectious from XXXX, anterior in RENEW. to [indiscernible] patients Nearly we inflammatory forward the in results of inferior anterior ocular reproxalap controlled in lead versus trial States inadequate, blindness. uveitis, the announced approach Phase zero we anterior the by eye reproxalap score of leaving anterior full in treated therapy uveitis the SOLACE two the sub-optimally many regarded this physicians results trial to not to can We characterized a SOLACE the objective noninfectious Sjögren-Larsson there is vehicle. of dry look completion which eye. uveitis, all eye primary in drugs X an timed design expect following RESET therapy. is Phase We The April, adaptive in intractable new skin the trial. to conditions completion can therapy by in of and year. patients are largest the therapies Part ever In of of as lead trial anterior cases other for The second disease part today The ocular could most trial. severe in year, disease, RESET in X first FDA the ocular chronic but uveitis. ichthyosis, to debilitating corticosteroid disease and is a part and approved and some in condition announcing previously trial as this of responsive represent the of a is which of complete in is trial the second The are a the untreated. which Thus, the dosing orphan part of and half no disease dry expect the we which surface. affects eye body cases and syndrome

testing, Following the results we completion of support to dosing size expect advancement the to endpoints and assuming the report for the the sample part first further regimen of remainder trial. RESET of

results proliferative RESET. over the report In no announced assess XXXX following rare months acquisition lead detachment therapy. there an to dermal blinding following clinical prevention trial RESET a two six disease and pipeline of clinically treatment. year, this and up the for we In expect January thereby The intravitreal months of and announced the ADX-XXXX of the but of full of expanded completion to with surface. disease retinal addition potentially reproxalap in of the is retinal vitreoretinopathy, topical XX% body significant reductions retinal of of ichthyosis will statistically of which Vision for We meaningful to treatment that our Helio drug we the occurs

remainder XXXX in regimen results post sufficient clinical We of Phase of of disease, expected clinical expect to are sample subsequent and of a testing program Phase announcement our X lymphoproliferative RESET we initiate year. testing are this on the in time, to of SOLACE trial assuming the the patients report clinical the disease. of year clinical syndrome dosing improving for from commercialization transplant hope an the suffering of a We on ADX-XXXX advance our execute pipeline to Based the be you and XXXX. as systemic to second trial well and initial our look pipeline, initiated X to immune autoimmune we from we mediated half as exciting. of ADX-XXX progress upcoming trial X this the for initiate across to lives disease for forward mission product advancement update half as first will expected immune XXXX Phase and adaptive expect the our we rest in of to of ADX-XXXX clinical endpoints In continuing size in intend the second mediated be of towards warrant

the XXXX financials. I'd call first our to Joshua quarter turn like back review to to Now over

Joshua Reed

Todd. you, Thank

is Helio XX, loss the cash related and tax from net XX, months founders year. expenses compared and $XX.X in-process the of no the the acquisition share resulting is development and increase development a administrative development the first million the costs, the $X.X accounting for liability last costs purposes during a $X.XX XXXX. to million first our and XXXX. increase acquired deferred approximately of General from $X.X XXXX, to were patent in for the to related a increase legal charge general non-cash and development arising for of the the research expenses related upfront the million quarter In acquisition. comprised compared For approximately research quarter primarily for Helio to $X.X tax to XXXX. the period for a and loss transaction related related have $XX.X for to ended of Helio a to Losses consideration million expenditures, prior per value net March reported to non-cash given for same year. was related for well of to compared we $X.X were the in operating million non-founders, personnel and compared expense The Vision development resulted $X.X in of million XXXX period of personnel primarily the clinical quarter first as the $X.XX cost administrative manufacturing, same was including same share first quarter increase R&D and million and $X.X and differences of costs non-cash approximately were compensation and million expenses. XXXX the quarter book to the were quarter March to as trial, the and net of such acquisition year. Acquired paid the quarter compared the first $X.X of There $X.X of increase our in-process of costs. expense stock-for-stock the $X related million The loss for clinical was Basic preclinical portion Helio. expenses to in costs diluted fair period the of charge of from XXXX the quarter research and Helio for of total an XXXX. from to last The research January a in the consideration program, million ended XXXX, per million charge an three expenses

The call on million In as additional funding first of April $XX through March of to result XX, option $XX.X with the total like An initial acquisition. our and elected your expenses provides our entered down quarter XXXX, expected for the of $X.X at development Operator, securities capital available the upon comments first we $XX the and and to XXXX. to XXXX. to questions. capital not term expired security option XXXX we’d XXXX. This quarter from of were concludes We end on primarily advance in to The at million participation. certain loan for non-cash a related of September equivalents facility up now in-process my million of draw charges you non-dilutive marketable first financing. the cash advances agreement Thank a research is loan advance, million in our that open into as loan XX, term connection Helio Cash, include XXXX. be conditions. which based quarter operating

Operator

question first Today’s Citi. from Yigal ahead. go Instructions] [Operator comes Please Absolutely. Nochomovitz from

Samantha Semenkow

Yigal. our Samantha question. Thanks for on much taking for Hi. This very is

could and your a you’ve Part novel in a on First testing to just phase novel of that of more noticed eye reproxalap provide X X clinical you the have same this the BID trials the And and why formulation reproxalap formulation the QID dosing Phase little here, the [indiscernible] different dry first context are there I wonder formulation? use particular this is that expectations is for bit you using of I in what [ph] you’re Thank initiated details in RENEW. dosing disease, if that rationale in developing are between like you trial? what you. and the of

Todd Brady

Excellent question. Obviously, Hi, for thanks dry eye we're question. Good morning very and the Sam. about disease. serious

We've point announcement demand of puts allocate Xiidra and Aldeyra in formulation. there eye exclamation yesterday's $X.X towards on disease here value regarding of sort to at billion this an think perfect space. I a never the the purchase dry and for decided resources is

novel design quite to you think increase at we're minor a the drug. as time trial change, formulations. good I In case, characterize formulation developing reference primarily resident clinicaltrials.gov the this that There of designed we're may on be mirrors But that’s other well. -- and trial you of the in benefits what the doing are as RESET correct obvious reasons. for that intentional, obviously trial

We trial. this are very about excited

in program We gives mentioned dry the us shot for way a disease, are very and trial the which is obviously yet as on I Aldeyra throughout RESET goal formulation very excited industry. about a high-value previously another for

Samantha Semenkow

changed little for strategy a your this on Thanks. That’s Novartis Is bit reproxalap? just more helpful. [indiscernible] acquisition. all [indiscernible] the at And then

Todd Brady

don’t And very acquisition, obviously, we view as acquisition. taking Xiidra We're committed a so. size to sign, of given the I the a as company to think of market. the products good

that that. is we Xiidra space the was large are quite the and companies much the in to forward. don't were quite think a us, we But didn’t high on see know eyes interested actually glad in Obviously, we for $XXX in I and changes the moving place million all I a are it about that think buy well Xiidra premium all companies [indiscernible], interested are -- we all, Xiidra. large so

superb and think thrilled in a As about I we previously we're advance molecule that. disease a to eye I dry have mentioned, chance

Samantha Semenkow

it. And SOLACE. what study? on us the [indiscernible] anterior the was just for X.X% uveitis. than Got the Could for the trial rationale noninfectious you vehicle as for was what last one me comparator for dose SOLACE in rather And using remind then rationale using the a

Todd Brady

on latter This of of uveitis one SOLACE, that and the disease. dose, a Noninfectious allergic the uveitis in very drug the what’s done X other highest corticosteroids. concentration of X.X% disease is are concentration. anterior in approved for non-inferiority testing is highest common trials is for and -- typically justification anterior uveitis uveitis based conjunctivitis, our It will concentration subsequent a answer the double excellent And against .XX%. noninfectious so for reproxalap our question. I the trials. noninfectious serious cause high blindness. is first. is using approvals the of corticosteroids we're dry formulation. Phase been Corticosteroids typically that’s only anterior class have

know, statistically bar. you high non-inferiority is As a

superiority In to regulators larger typical able thus requiring that aim the Again, non-inferiority and against run fact, is for a were study trial. vehicle steroid. it be could much higher that bar versus easiest, We to much with the sample which sizes superiority. in is agree we than hurdle a a thrilled

may to get flaring better very understanding Noninfectious of take get for time anterior time is weeks that respond get a time, the vehicle months. that So regulatory is for was to simple us that is win. our on while long a may patients that is and very uveitis disease, a worse they real course patients The so and reason better. eventually,

as damage front mentioned the pick zero time So more we cells The to SOLACE that's therapy to with trial that to four suffer is weeks the in and permanent important. time cure endpoint is or a likely the is of cells anterior of longer in patients of that to the I have why eye endpoint chamber time inflammatory is that the is cure precisely and eye, result. the vision the

designed as the why the that's is. reason trial it so And is

Samantha Semenkow

much for the taking questions. Great. so Thanks

Todd Brady

Thanks, Sam.

Operator

go from Adam And at our Stifel. comes next Please ahead. Walsh question today

Neil Carnahan

on for Carnahan Neil It's Adam. guys. morning, Good

results about you the an treatment follow-up. then, the sufficient appetite steroids along Xb Just treatment got with to I’ve question, alternative an X trial And And bit NAU NDA? this a NAU? the Phase one will support can Phase talk to following for community these for on for in the

Todd Brady

of for Sure, disease, this Corticosteroids have Neil. long time them been for thanks generic. Yes, the are a many approved for question.

and generic the corticosteroids strong, not of inflammatory penetration for ocular diseases. [ph] is corticosteroids other in very dominant generally corticosteroids this space the branded presence disease Although, ocular usage in for the that’s the

with obviously, requirements satisfy effectively. ask to branded is So is correct question an I and think regulatory is too The And the in I the large for here. standard well-controlled filing. you marketing, entrants of compete very think, FDA NDA the the [indiscernible] know new can interesting. standard different any promotion don't trial that I clinical that

However, considering year. these will cataracts, even glaucoma. need result steroids, to an Chronic noninfectious of relapse toxicity anterior is rare patients to develop steroid of X many will Most There unmet is a steroids these high disease. to of as They lead uveitis their in recur episodic of terms patients extremely flares. can will of use a of therapy. X Xx partially the eventually

regulatory there to levers to with follow an course be accelerated argue for can we that So some may authorities approval.

this However, our pathway approval standard applied. at point assumption is the that

Neil Carnahan

Okay. of Part study And Phase [ph]. program. then the one the got on Part of I that similar The same thought the is for eye to ran X dry X Phase -- kind Xb X the process follow-up

Thanks. those significance see possibility statistical the to for But if I Part see endpoint the for in you you study. a results, on If could there that in be inform know plan on X is significance considered the study, that that is powering statistical it standalone of trial?

Todd Brady

Thanks, for Thank that Neil. Yes. me you question. asking

the parameters -- of to tested any there's are any initial adaptive that confirm is if by dosing adaptive I fiscal significance phases of is adaptive appropriate. in adaptive question aspect results the think the to reason is The phases of trial trial the going the these A in phases is trial of there forth. trial etcetera. sort hit of the be is description not the and with of used were that of answer trial a always trial, the the the if are first And endpoints early a trial, latter in and certain certain your endpoint right? to yes. just first success, power trial the possibility a can long and trials our words, trial significant There grounds short brief of answer is confirm other keep so on terminated no adaptive statistically

trial not But how the adaptive of is obviously mentioned, you point an Neil, designed. of certainly that’s any trial. the scenarios that's not initial but there's upside adaptive some phases However, really

just what trial said I Sjögren-Larsson that I intend trial and potentially X the proliferative think this not but trial the adaptive we RESET in also syndrome dry year RENEW disease, vitreoretinopathy. to and applies later only to the in initiate Phase

Neil Carnahan

Thank you.

Operator

And the Janney. of Please comes ahead. Esther next question go today from Hong

Esther Hong

another quarter execution. Hi. Good on of strong morning. Congrats clinical

So you expect allergic would to potentially -- Phase -- follow-up comments that. Phase out? then that complete conjunctivitis if expect study and in And study have another occur you X to initiate eye in uveitis would study, disease NDA the just another filing can X on on required, this do then and dry or is read to or so Any complete to another we when post Thanks. parallel?

Todd Brady

question. for the thanks Esther,

Your about uveitis? question is

Esther Hong

Yes.

Todd Brady

and think for I standard Yes. Well, two that mentioned as I trials previously, that is filing. NDA the

highlighted the strong, testing to of of some they than required it disease. typically may results needs the severity are given that I especially clinical tremendously If do and the that think potential on I there think less for medical the I the depends it argue trial. SOLACE be

that to may are earlier and sequencing product of about uveitis different we they’re the the of uveitis, product different concerned that’s products, question. occurs given, that’s That be to concentration sequence in different a comes reason treated. reasons. of And dry that conjunctivitis tapered that down I for conjunctivitis. allergic the mean of of typically product don't dry precisely dry Sam's the question are I treat allergic how theory in the particularly an programs, gets there how disease Therefore, uveitis in safety by about disease often say the that is frequent And back disease. different a in initially The SAUs. terms kit, dosing steroids given and uveitis concentration from and The relative to from although over in In steroids I time. a .X%. versus the is That’s administration is know that programs are other conjunctivitis right? excellent way flare allergic

the out the pointed to therapy. Although trial as has taper of a assessing weeks been XX RENEW we are in BID throughout QID

Esther Hong

Okay. Great. Thank you. All right.

Todd Brady

Esther. Thanks,

Operator

next of question Matthew ahead. Cross Please And from JonesTrading. our go comes

Matthew Cross

Good this to timeline morning start congrats also of can announcement and another it half, guys. your and Hey, standard in taking a presentation beyond mean of that timing SOLACE your this pretty [indiscernible] to down off what recent given to you of second the dosing clarify, and then hoping way? kind of could the to have for trial. we thanks Does secondary inept and my completed flare to experienced endpoints possible the for bringing data expect clarify zero? the maybe that could progress, see to on patient of or patients Wanted all And quarter you’re as flare their flares from treatable is that cycles the leave primary question.

Todd Brady

for Yes. question. Matt, the thanks

So resolved. the last is completed visit dose last flare the the patient that what last has and has means that and

are looking We flares. at only primary

they active be have flare. have So subject trial the the to but only noninfectious not anterior have an uveitis, into to to be to enrolled

[technical the active difficulty] is So designed to flares. treat

are that flare. April, So announcement for enrolled the last completed on flare our that based are in in patient has dosing patients and

a our I So, to something anything see of results trial is don't process think last gave, from patient but hand XX-day -- all statistics the out us. that and thus standard we is timeline for to happen. fairly industry yes, prematurely, last visit the it's very the adjudication here certainly will until don't a on given your just a that take results to It we’ve now, and forth queries X very We Matt. I X important typically standard I expect release Phase very, the data from data I and I from announcement across data can of that. apply think confirmation differ so Phase materially we But and on like guidance to a trial, intend to and to seriously announcement rush

Matthew Cross

for you we FDA second some allergic look great. to Okay, Phase I about endpoints feedback? hoping what for had of hear the these as ongoing lot based clarification. of like and on same And a the feasibility X was Thank discussion in then could studies far SLS. as this conjunctivitis

noted on design the endpoint, [indiscernible] You’ve side element. now

For here? Part can X, the the anything being some other about is I some employed endpoints or it's Part possibilities in measures alternative? one But completed. of and for how consider you validated of what are guess there visual that say say [technical Part assessment reliable would X are X would are you you or difficulty]

Todd Brady

unique portfolio no not And in Right. is this ultra-rare And condition. flexibility in in Excellent large condition trial controlled that's Sjögren-Larsson question. validated endpoints are endpoints. is there ever and there case often SLS an per why because around some been ultra-rare has it's our syndrome.

some off. does and moisture cracked skin bacterial It that and to characteristic not adequate I a that, it blood clinical think the which mentioned of characteristic is these have dry, skin The earlier excessively cases disease severe all patients. said intractable infected. gets is overgrowth clinical scaling. The that bleed ichthyosis that having putrefy foul is odor I flakes However, this key supply. and leads It and do and in

means the but clinical characteristics. is is scaling what the key this severely actually a scaling debilitating ichthyosis part -- which ichthyosis So condition, of is

that’s Part as suspect scaling. X. would of we’ve So, focus that part around And released I what endpoint the

the We some have assessment to quality made modifications the at of scaling. enhance

parameters. know, two you As we’ve different

a a We have assessed time. patients digital investigator then over we that central reader photography and have scale of reviews the

broad of within parameters, think I in regarding [indiscernible] terms scaling. endpoints something that of So set

Matthew Cross

Got it.

[indiscernible] more prior as can terms well. of helpful for That’s which the expectations as one ALLEVIATE your timeline as was for one over terms of an quick squeezing -- housekeeping full to comparison [indiscernible] far us just nature? and presentation in or in just of of wise setting any update give trials time [indiscernible] details Okay. like [indiscernible] you

Todd Brady

might expect data we at announce full you candidate the I'm to which a that. guess, conference. be Yes, ALLEVIATE major for ALLEVIATE of can one medical a sure

in minimally those and this sizes full see very more hope would I so disclosure will -- for something ALLEVIATE. important sizes later data differences that data and interested a are that We by you'll be to year. and [indiscernible] of relevant [indiscernible] be effect -- clinical of, forth mean But something released I will

Matthew Cross

Fair enough.

I think Thanks, guys. with does me. that

Todd Brady

Matt. Thanks,

Operator

gentlemen, thank and this you question-and-answer for session attending We and concludes conference. today’s ladies today’s And today’s all presentation.

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

Aldeyra Therapeutics (ALDX) 9 May 192019 Q1 Earnings call transcript