ALDX - Earnings call transcript Q3 2018 | Aldeyra Therapeutics, Inc.

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

Operator

Good morning and welcome to the Aldeyra Therapeutics Third Quarter 2018 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Joshua Reed, Chief Financial Officer. Mr. ahead. go please Reed,

Joshua Reed

With I And Reed, Therapeutics welcome our of financial to everyone. Brady, Dr. of Executive Chief conference Financial Aldeyra discuss Officer results. XXXX quarter Therapeutics. to Therapeutics. third today am morning, is Chief Todd Joshua Aldeyra Officer call me Good the Aldeyra

you a press would quarter financial containing results the as the third started, Before remind Aldeyra. important conference that release we we information. get the this performance future statements call press you XXXX. to I it contains contains encourage of of to and release regarding like morning review we filed This events future for forward-looking

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

differ factors the in Additional cause information the are and with SEC. Press materially that from the statements results Release greater concerning forward-looking to company's our in could described detail company's filings

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

Todd Brady

you, Thank Joshua.

and sponsored The trial clinical announced our trial mesothelioma. trials, quarter in eye in Clinical third positive results an Aldeyra, clinical was quarter Phase another two investigator important ADX-XXXX landmark disease from for of we IIb as dry

our line versus potentially early a after care. candidate, signs modest was ocular and generally therapy the currently from a occurs where broadly active efficacy, that most activity weeks reproxalap consistent available a clear In and drug where as in finding variety of require of physicians and terms of two physician a of across of therapies and even topical factor first important market and reproxalap, perhaps, dosing, appears commercially product or differentiating standard may perspective are as vehicle demonstrated the symptoms, our patients disease, efficacy could initiation weeks a months with dissatisfied or

often the end is condition the in that we As the following for eye disease an reproxalap that high. therapies major of the many II interesting year. disturbing and fact that dry allergic broad is FDA, Relative novel disease the therapeutic affects of of eye you disease, to a therapies, uniquely with patients determinant United approximately a believe million conjunction to early profile to based And therapeutic know, Phase demand particularly disease occurs we Pollen reproxalap approach XX a discussion has irritation. ocular reproxalap Phase with III an other dryness in dry to dry a testing demonstrated in condition clinical is Dry expect States. potential And Phase represent clinical on the of the in persistently due XXXX, and next in important eye IIb conjunctivitis, results, initiate potentially disease. eye is efficacy eye has dry

reproxalap III previous to activity earlier ocular trials ALLEVIATE uveitis, allergic results Phase demonstrated reproxalap noninfectious was noninfectious can uveitis, look intractable to year. results conjunctivitis, results increase Based skin did corticosteroids and next Syndrome, were to III to that year. clinical SOLACE half also be disease, the disease reproxalap chthyosis. in Phase anterior and we the a from formation. of eye successful potential Reproxalap observed lead an for trial and in cataract X anterior we to is error an Trial serious unprecedented activity, was that demonstrating metabolism clinical Phase lead And And next results ocular and blindness. Phase the we Following clinical last clinical trial severe therapy track but initiated patients, corticosteroid-treated can track demonstrating remain orphan disease and two Part used of Topical to early known the but intraocular is earlier announcing initiated a not III the as glaucoma initiated that a we II Topical this Sjögren-Larsson announce second the Phase on rare trial on on of noninfectious also RESET ocular announce corticosteroid of II results toxicities, the Phase was III severe characterized and treat lead on year. statistically including II remain autoimmune pressure year. inborn to Phase as by in therapy Based forward this this year, and XXXX.

in and X World announced Phase a will the prognosis. quarter, filled results stage and cancer Part MESO-X In We in Cancer Aldeyra with represent In a investigator-sponsored late available catalyst a to typical announced. the were sponsored from trial malignant to results ½ Phase the on at with mesothelioma, of to contrast, XX%. be Conference poor are were currently response expect XX% trials the rates XX% the report clinical SOLACE III Lung from that ADX-XXXX pleural XXXX expected rare RESET year trial pleased terminal therapy, the response ALLEVIATE, third September, of but investigators rates we for as positive

regulatory II clinical with next We trial a discussion initiate to expect year pending authorities. Phase

for ADX-XXX We and for post-transplant cancer. lymphoproliferative are the in disorder disease, including retinal disease, clinical XXXX ADX-XXXX initiation and also ovarian testing earlier our planned excited for for ADX-XXX programs, of development immune-mediated

the to third the over financial call like to turn quarter discuss to results. I'd back Joshua Now

Joshua Reed

Todd. you, Thank

per pleased increase and General compared consulting $X.X were increase in $XX.X October the million of and public approximately development million of period $X costs, administrative expenses. $X.X legal costs clinical million patent-related and million cost securities diluted XXXX, were cash million $X.XX to reported XXXX, raising XXXX, for loss $X.XX a we net Cash, of net third compared of XXXX and we third the trials and quarter million as the year. $XX.X in were compared quarter of as was in XXXX. of of to research to per loss quarter the For as approximately expenses an million have the offering quarter from close to costs. our in The related for manufacturing, and primarily last XXX,XXX and share increase of development net costs $XX.X preclinical expenditures, the the personnel $X stock, approximately primarily development the third operating for $X.X personnel an year. The marketable costs. $X.X general period clinical million research $XX.X is year. discounts, last million and and million well to third million were third year. to of of expenses Losses administrative the period loss after underwriting of from Basic R&D In underwritten our deducting an resulted same expenses. related quarter total XXXX. programs In for equivalents last the for same net of in for to including expenses of the compared proceeds quarter prior of increase to million share estimated of $X.X same were a $X.X and compared end commissions is common the increase shares and and

the in clinical We III anterior NASH be top fund end trial III in from and operations trial in the lymphoproliferative Phase Phase post-transplant XXXX, Syndrome, the to in Phase data the in currently expect planned a conjunctivitis, X RESET Phase our flow of Part Phase current Sjögren-Larsson eye Ib a cash including the our allergic is will Phase showed line IIa in through III dry disease, disorder. trial clinical noninfectious uveitis, sufficient SOLACE the of trial ALLEVIATE clinical of trial trial III announcements large

our be of across Additionally, are for sufficient are believe we please on to candidates. In questions. for will mission That summary, remarks. call allow well-funded technologies in-licensing to mechanisms complementary we multiple current our open and candidate that developing Operator, actions of that product funding therapy novel immune-modulating our we pipeline. of our execute product concludes multiple the to believe

Operator

comes question-and-answer [Operator go We Adam will now session. question begin Walsh Please ahead. from Stifel. Instructions] with today first The the

Neil Carnahan

guys. Adam. morning, for This is Neil on Good

Just you’re thinking Phase what us on III disease far as in the you talk question dry about there, inclusion a to eye specifically patients? criteria study. severity as Can of Thanks. just on

Todd Brady

therapy, very It's more want to of be they're enroll shrink Yes, thanks you more The III is respond. Phase severe, inclusion less us. terms patients they if IIb be standard the are very if either Neil, question to in placebo will the enrollment. there to yesterday the differed hosting IIb that criteria. to Phase that dramatic thank conference. a similar sequel because miles too in also for opportunity And vehicle of Yes, a industry us companies two is or to to Phase going because that then the not are the terms enroll response. don’t patients the is similar for attractable so at And for and

in So IIb, premise continue moderate in patients will that that we are generally Phase we Phase enroll, what most stuck trials III. to

and IIb. results as impressive little can we to Phase So hopefully change observed possible we in as as the that replicate

Operator

go ahead. with Company. question I-Eh Please from next The Jen comes Laidlaw &

Unidentified Analyst

of wanted in other Hi. post-transplant in ADX-XXXX the ovarian? lymphoproliferative with How I-Eh This of to clinical you guys to this I you cancers as speak is do Chris of speaking such compare upcoming on dosage the trial behalf Can dosage Jen. that? ask, syndrome.

Todd Brady

a That’s question. Chris. great Thanks,

say, to think, solid-organ about ocular, leukocytes with immune-mediated stages, PTLD is in excited disease represents, efforts a that the We’re dermal. to of product is new first serious of our a one predominantly our very of disorder by strategic programs following hyperproliferation transition which should I addition, systemically caused or major topical our systemic I transplant. general pipeline, This topical candidates. late

Now patients there. picture they’re being -- issue transplanted of the orange, why add to that health, that’s transplant, the to have

the Some these generally The will to used we in this have hyper patients doses test do previously to of of XXXX MTD MTDs doses. of that ADX-XXXX. proliferation not get And with lymphocytes. with lymphoma tolerated XXXX. trials is that We disease are test of been that are intend patients intend like cancer predominantly maximally doses a

away and cancer we generally, in I the index that all get generally with manifest not therapeutic per is therapeutics, is cancer our lower a of which causing se, without still could thereby doses And disease think drug, toxicity. be increase PTLD, in those efficacy toxicity.

actually trial trials. when initiated, past, than So see cancer in the are used about year I more it's as you that using the and the what lower in think find details we’re doses next been has you’ll

Operator

from question go comes [Operator Hong instructions] The Esther ahead. Janney. Please next with

Esther Hong

IIb Phase can Phase changes remind the of second, those allergic III the would in impact Phase you then and you how design, impact in conjunctivitis, in of allergic us potential studies? any study And And trial first III second feasibility study the the can conjunctivitis? updates the So, changes? the in provide ongoing Thanks. those from on

Todd Brady

There little The to from is very IIb more is ALLEVIATE the Phase trial III change major change allergic conjunctivitis. patients. in Phase

the Phase an allergic the directly with challenge provocation we’re the trial patients this has statistical vehicle allergen been industry doing exactly study, eye arm. XX the decade As is approximately so. in We in the drug was with That exactly conjunctivitis. differentiation IIb recall, Phase over what trial. a in that That’s past is between were to trial. what ALLEVIATE in per and allergen the that’s impressed you IIb we standard did administered where or And the

over minutes. antihistamines itch over that of antihistamines patients minutes. X, As patient, XX% physician, no itch you score don’t powered to incapacitating recall allergic and itch is as even What’s and four seven very happens sort are care concerned about the XX Thus for measured meaning over think a about point, standard itch most trial minutes. itch, is is patients we and know, XXX which as primary arm. zero over of area what about I are the a end And our conjunctivitis, in scorecard, you to is ALLEVIATE many per of the that’s as interest seven most meaning X under was a measure us

ALLEVIATE more we’re much the think III long-term Phase exactly that’s after activity. we’re works, trial, in and it's I exactly challenge. how concerned about And allergen what reproxolap testing the

your relates Now question Phase the next trial. III subsequent to

other well-controlled two an allergic approvals. and trials you disorders know, are non-orphan for As large required conjunctivitis

trial Phase exposure to environmental will based The III on second allergen. be

and redness the is in So two instead eye, the during allergen one environment. a be directly administering they of patients will so to allergy and flavors is diary, and environmental exposure; and itch their are administered trial, Patients to a on. There know allergen other season. where field have of drug symptoms

room early defined exposure top have development is is of in second small and ongoing on X ALLEVIATE trials allergen of methods flavor how and over of the that those other could the line And results which I and aerosolized your hear X to next to mentioned are are in time The from moment. a enrolling year, period expect kinds informs we is expose Both of the around think, that the that those a preliminary hour allergens patients quantities in clinical at this where then to us trial air. the results, chamber, the methods-development those Phase subject question. you essentially III you environmental

Operator

our be to Thank Since session, there attending this presentation. question-and-answer today's and you our conference. questions, for appears no further concludes

may You now disconnect.

Aldeyra Therapeutics (ALDX) 14 Nov 182018 Q3 Earnings call transcript