ALDX - Earnings call transcript Q2 2019 | Aldeyra Therapeutics, Inc.

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Operator

Good morning. My name is Carol, and I will be your operator today. At this time, I would like to welcome everyone to the Aldeyra Therapeutics reports second quarter 2019 financial results call. [Operator Instructions]. At this time, I would like to turn the call over to Joshua Reed, Chief Financial Officer. sir. ahead, go Please

Joshua Reed

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

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

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

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

Todd Brady

commercialization. share towards Thank you, candidates the you with progress to This Josh, our we've excited lead and thank in I'm you us. all for morning, made advancing joining

months. In addition to the to the we milestones in expect announce coming

of eye Phase RENEW to First, trial Part adaptive year. in complete dry quarter in fourth we disease III X the of the expect this

clinical We from Phase size disease. Top Part dosing and that we be reproxalap the approach eye from expect are line advanced X dry following expected Part activity, regimen rapid potential suggest reproxalap symptomatic IIb XX Part most is of RENEW patients, the and clinical could our portion competitive report of that a treatment successful, are approved, the to trial of year only strongly X. III of Results more if reproxalap, has therapeutic trial. offer us which if of to X, the from completion for than completion significant of disclosed novel in released treated market RENEW development broad believe to results the million the endpoints, share Phase for Thus, sample are which Following trials market-leading, and a differentiate current last small onset with capture therapies. programs.

to the intend our trial III we which addition, expect to the fourth allergic quarter this of FDA, finalize Phase second receive clinical feedback following in In in from we conjunctivitis, year.

Phase ALLEVIATE this June allergic ocular a response itching significant announced number the to is suboptimal conjunctivitis. the afflict conjunctivitis and III and in of of demonstrated standard and aggrevating population patients worldwide, The trial significant announced symptom of care. allergen clinically-relevant March reduction highly-statistically of to Allergic nearly chamber estimated chronically trial report X/X of in in those year and

the we believe in new conjunctivitis represents reproxalap years. treatment over for of the mechanism Importantly, that first XX allergic

clinical retinal which for first program, GUARD proliferative no a and of potentially Aldeyra disease trial rare exist. our PVR a PVR. ADX-XXXX as blinding therapeutic marquee or we Phase for XXXX the options represents disease is initiate and year III vitreoretinopathy,

this enrollment FDA trial the initiate reached on fourth We to expect the of in have year. agreement with GUARD of design the and the quarter

to inhibitor ADX-XXX, mesothelioma first investigator-sponsored inhibitor post-transplant programs ADX-XXXX, is to results clinical disease ovarian that immune-mediated from systemic novel response based trial XXXX, substantially standard subsequent testing, care. treatment I Phase on for to II of a the a chaperone and initiated of to cancer, for expected development of Phase rates expected expected exceeded ADX-XXXX disease that be A in also we testing also is next investigator-sponsored year. called a ADX-XXXX immunological clinical initiate in an our syndrome. mesothelioma demonstrated In begin in intend and RASP begin lymphoproliferative rare trial

In of addition, cancer an investigator-sponsored trial ADX-XXXX in is ovarian ongoing.

We for investigator-sponsored resources us development our advancing allow on which have oncology. support opinion programs, the later-stage the pleased significant ADX-XXXX prioritize to leader key trials, to are while financial garnered in of

for metabolism III dermal skin. also a drug-treated We patients of scores known as part which in a the in greater discuss of scaling adaptive adjusted literally X the treated inborn were X subsequent the to therapy therapy. Part completed that months results recently orphan vehicle baseline RESET We error numerically by regulatory statistically with the over six improvement, trial Syndrome, was skin rare tolerated. to intractable disease and indication of means Investigator severe and scaly Phase assess in X patients prior the values Part authorities initiating RESET Sjögren-Larsson was This than with in six Part lower when plan ichthyosis, testing. clinical of score, well pretreatment than three characterized

our execute have number therapies establish work reproxalap fulfilling our frontline mission high with I we we on to the and immune-mediated a with ADX-XXXX as summary, And diseases medical for clinical of the towards patients need. disease. catalysts in summarized as unmet continue to quarters morning, In immune-mediated this to strategy of as improve lives we have coming

second to results. call our financial the back to Now XXXX Josh? I'll over quarter Josh turn summarize

Joshua Reed

you, Todd. Thank

million based well our period subject development to continued quarter XXXX, manufacturing, per approximately reported in clinical costs of that $X.X have of of expenses. increase second were loss related same of from as approximately the on For for quarter and XXXX. Losses per vesting Basic quarter XXXX research share the a Research the for for million $X.XX $X.XX XXXX. to portion for increase the and costs from a programs net consideration million The expenses compared cost general million for of $XX.X of costs, of compared noncash personnel same diluted to in development to share compensation loss resulted a $X.X $X.X last year. and the related was development in upfront an as and primarily and period to is the net $XX.X preclinical and the loss the administrative million compared second service. we net increase quarter second to of are

for related to $XXX,XXX and General $X.X compared expenses same the quarter last marketable operating were equivalents increase of to the primarily compared period is $X.X as million an in increase million of for quarter were In million expenses $XX.X year. Cash, the second XXXX, The million personnel securities second second of of total $X.X cash administrative year. XXXX. the XXXX quarter $XX.X to in the of of million the and prior end were costs.

Thank comments Operator, to participation. the the my concludes you financial we now call like your would on This second for questions. open to results. quarter

Operator

[Operator Instructions].

today Our first Yigal comes question of Nochomovitz from from the Citi. line

Victor Rusu

X on Victor eye of we Phase trial is have in dry for the is question One This Part III disease. RENEW for Yigal.

You and to assess separate population ocular Will fluorescein prespecified prespecified two to on dryness fluorescein will specified fluorescein two ocular scaling vice in population? you patient versa, staining three, nasal greater equal or at you greater assess or score dryness dryness based population? ocular And nasal equal score baseline. the staining nasal the in

Todd Brady

no. answer The different for Those populations. prespecified Thanks two question. are is short the

high-staining will score population. staining from easier the in scores. be to dryness in will the in and assessed baseline changes be score with So that that high-dryness higher detect are is patients The patients reason for baseline assessed

impossible say, in from baseline score, cases. some detect are close patient to if a a imagine can low zero, changes baseline with let's in to comes You

necessarily. So with not that what the some analyses populations but agency, agency that's overlap, have the the in separate has populations why to to we prespecified may high-baseline agreed two and amounts patient

Victor Rusu

two brings prespecified And Great. second How that you me question. between populations? do much expect to overlap the my actually

Todd Brady

to only saves of staining that at enrolled on high Hard the can the Phase and has in trial count is But know. endpoint. scores a high patients of us significant staining both enrollment. beauty IIb the And trial, the have on roughly the high-baseline scores. the that will dryness patient and high-baseline time still Based dryness baseline that be towards primary trial or half

Operator

Our from Stifel. Adam line of Walsh from next question comes the

Unidentified Analyst

[ph] is Walsh. for Ng Adam of trial. the enrollment Congrats This on the RENEW Edwin fast

are second quarters? and you please half II or may on us including you on this criteria TD Any Can My the the some the major the the question remind There inclusion next color trial? the activities, some following as can be on previous patient? Just Josh. from changes of year. question, clinical Phase us second give R&D in exclusion few of for the please the initiations new trial operational in quite expenses trial

Todd Brady

or key the thank II, Edwin, the Phase for criteria of the criteria of essentially eye to of results patients fewer in in as in both of choice. dryness for so, Phase intending on both variables replicating meet we we're enrollment enrolled IIb, for patients one The symptoms we're if IIb staining. better, terms Phase in Phase an significant change criteria be staining either staining. criteria Victor, dry you enrollment at terms are dryness trial. or certain intentional must must your III and in in in or the dry with history are months a And obviously Phase and disease baseline, eye as and that's discussed and same The III to highly-statistically question. just a high-baseline both six be essentially The in

Joshua Reed

be two are your on question, achieved. part yes, when based on of variable milestones can And expenses R&D somewhat

in expect in you of given to should that half accurately However, an we increase later out, expect year, year. the our R&D in costs you as see pointed the activity the this second

Operator

Our next Esther comes question from Janney. from of line Hong the

Esther Hong

on progress. all the Congratulations

are Phase X Part from in we stack Part X then for details RESET particularly that with expect And to III regards provided RENEW Syndrome, eye, seg. similar the some can the in Phase of expect of study dry in we what the to those III high-level first, study can Sjögren-Larsson? in Part So Sjögren-Larsson of X trial

Todd Brady

subsequent One size from on move is hear The three sufficient any tap Yes, pivotal is of the the can RENEW think to forward. design that with to something initial Generally, outcomes, patients, today are run generate Thank for expect outcomes. trial intent to I question, parts similar you there potential to trial, adaptive initially us trial I adaptive that Esther. patients, us of from the you any then trial. heard spec think about you to didn't RESET.

certain X after point the for that Typically, Part The would do then expect in on And patient particular, needed is there's size what that in third Phase and I other RENEW enrollment so the X parameters. expect is the Part what eye primary The endpoint. X continuing of to X, the to Part confirmation trial advancing potential so the trial. number to outcome trial dry III trial and we're we that patients is -- forth. of based of in Part for hear works well no of the

a sort from adaptive trial of output So part. that's standard first the

regulatory the drug with Sjögren-Larsson Part on concerned, I far As is discussions Obviously, as we think, authorities. saw X, depends our activity.

we rare path tolerated. As the you well Syndrome, drug is Sjögren-Larsson as is was the uncertain. regulatory know, mentioned, and a disease

discuss of And so we to both outlining the and intend moving forward. design FDA Part before with the that specifically EMA the before X

Operator

comes Our & I-Eh Laidlaw Company. next question Jen from from

I-Eh Jen

in the that? RESET would for Congrats on Phase on one? the first question in study that to some Syndrome? going previous -- RESET you compare advancement reveal quicker My all, have of the Sjögren-Larsson that you preliminary -- data study all readout are details II the you of First the And do how is of to fronts. more --

Todd Brady

That's results interesting question, had forward. I-Eh. with wouldn't we Phase not the And that first been, the are you the they be can consistent even II. if part. for moving tell Thanks very I

influence in or are of we patients our general, and either the disclosed So trial of And RESET trial, trial, as unduly the or as investigators in we've companies affect and during think, ongoing. middle the not as quantify adaptive to so previously, right? the is a to outcome positively I ultimately trial not negatively. tend enrollment

the our So in conjunction and with feel of represents DSMB comfortable investigators of disclosure. we our amount what today in the announcement terms

I-Eh Jen

And scheduled or you discussion year? the with agencies, to in have be are when fourth Great. would third also quarter that the this of

Todd Brady

it's the Europe. but not it's just FDA, complicated Well, also process a because

Syndrome and in is Sjögren-Larsson that worldwide previously, discussed we've Europe. well-described particularly evident As first-described

process particular parallel that means European the where the we're at kept we're All so that the in this it regulators time, is complicated. U.S. And terms very and on timing. and informed simultaneously. approaching keen scheduling both on so-called that agencies And timing of really a are depends

I-Eh Jen

the question and the is challenging allergic environmental Okay, great. which for report more one conjunctivitis, and just then that. earlier successfully studies have maybe And tested you here,

that, study? speak So before overall, that in it the may you within something second -- for to agency that share present the was any with them? context, part And the there other of will Phase you is you colors the III

Todd Brady

conjunctival Both a are eye. the data, will was deck, -- which allergen in trial clinically meaningful. directly ALLEVIATE, both the corporate statistically-positive our the Absolutely, the and administered challenge agency. discussed be to that which with are strongly, is chamber allergen trials And

redness. in the levels, levels, controlled for as now and room, into will is administered we've challenge some conjunctival certain environmental itself. only data drug terms propose with previously of and And are drug small challenge. in of trial the ocular I X completed think rate III but X of pollen, assume, an it's were blown chamber Phase successfully vehicle is that remarkably itch a and in Those is disclosed positive the reasonable at or itch, to either the challenge, room, then that challenge, go sit a the a environmental hours cases, we've into patient we ocular to confined there patients example an terms not vehicle agency that allergen administration, after positive, during

think agency So be an discussing the is that with assumption allergen your accurate. we'll trial I

I-Eh Jen

the congrats Again, fast on movements.

Operator

Matthew question from Our next JonesTrading. comes from Cross

Matthew Cross

bad Congrats how how de I'll start prepared But particularly thinking landscape? an one, dry this You you on market, if best a a acuity I'm need feel do you existing you maybe of it progress But little have far size I much me. outcompete guess, Or those effect show least lengthier to, problems do wondering to a with compete need novo the I excited you think your be with reproxalap then to follow-up fit that the was that allergy. on from clarify Is rapid kind Xiidra alluded just with about hoping patients the enough then and there into use really of seems about of like to could of Xiidra? reproxalap visual kind and And saturated? forgive for effects to eye isn't RESTASIS. market dry do is? side mathematically eye taste? bit with physicians you quarter. remarks at with where overlapping kind in to get superior need most, this? I you'll about we a

Todd Brady

million disease. Right. one would don't interested well-characterized in work of that And a the very as is XX-plus market second RESTASIS patients or you two with dry drugs. onset taking And in there's persistently Xiidra, There's Matt, be the in is patients taste drugs well. patients eye only suffers the the reason Xiidra disturbance, either from this of of that itself, more of suffer if annoying patients are because particularly look as disease it's is side we low. I'm But view, that that the treated number dry that them. at Otherwise, eye is Xiidra our from actually think is two itself. critical effect that action. that issues: some for

RESTASIS, work. serious you of taste compete eye. the Xiidra any As offers, no the or but months that or needs we're you with side advantages obviously to there's weeks that disturbance itself, reproxalap I in that reproxalap, often don't reproxalap know, these administered other or to effect to aware with drugs directly when take imagine know can

other critical may advantage And action. that onset is the rapid reproxalap of have

is I a think results there from Phase of market-leading as reproxalap one working the week see results soon Phase therapy, that can II and be you potential could the which is as IIa that the characteristic. that

on eye than thing is I'll other dry more other say drug. and that signs disclosed we've data symptoms any broadly The disease

are think reproxalap's tear there or really what's of Schirmer the variety different we to look osmolarity, is what different of release, of clear this impressed very of very across is that IIb and I our today. much active slides deck profile, a between to breadth data. across is to reproxalap data test. versus seems key volume and opinion This compete the safety and the release it was in variety unprecedented certainly out at If unprecedented onset and with symptoms, the broadly a action signs, leaders clear to you quite the tolerability in staining, the it's and activity potential corporate slides and And Phase be

Matthew Cross

has But mathematic to And vehicle. as improvement of then we're that deep benefit RENEW for imagine too the you know Absolutely, fairly come been any But is is speculating Obviously, about out what on impressive more going. kind a we're keeps mentioned recapping would significant transient. I might agree. showed data baseline, but that. as not as far digging regulatory X. that thanks SLS, and these reproxalap to discussions this of as And I from Part today, SLS, same cases hoping statistical see likely from be of very in improvement vehicle given in over a

would that sort utilizing to like are see any in today? that of a you're potential of Or you suggest some Part you'd to any open So validity X? changes kind measure in other durability there discussing

Todd Brady

All kinds of possibilities Syndrome. with Sjögren-Larsson

one previous another in Most As patients demonstrate the standard opportunities a really with orphan on standard for orphan six in from various it's that generally. eye distinguish But us patient path hard instance, say, in And to techniques patients dry work for a have to on the presents the trial don't activity with apply. a of group three is mentioned that disease agencies the using case statistics. I untrodden. allergic and use, to disease and answer, might regulatory actually vehicle, we or drug these diseases few that's conjunctivitis with

the you to of which the alternatives, suggesting some And authorities shortly. so we'll regulatory of we're along what lines kinds suggest open to be all of

Operator

Todd the for to remarks. Dr. turn back now closing call I'll Brady

Todd Brady

disease. as quarter advancing informed our and for Thank immune-mediated and keep product we We progress to all treatment of our you, of the today. fourth candidates late-stage for busy pipeline a joining thank forward us you of operator, look you

Operator

This concludes conference. today's

now disconnect. You may

Aldeyra Therapeutics (ALDX) 8 Aug 192019 Q2 Earnings call transcript