ALDX - Earnings call transcript Q1 2020 | Aldeyra Therapeutics, Inc.

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Operator

Good morning. And welcome to the Aldeyra Therapeutics First Quarter 2020 Financial Results Conference Call. After the speaker’ remarks, there will be a question-and-answer session. [Operator Instructions]

At this time, I would like to turn the call over to Mr. Chief company’s the Reed, Financial Officer. Joshua ahead, go sir. Please

Joshua Reed

Thank good everyone. you, morning, and

Commercial Dr. with and Aldeyra’s Chief call the Todd David me our Officer; On Executive are Brady, Chief President McMullin, Officer. and

overview will of will clinical I take concluding Todd your discuss will comments with results. Todd first financial make our questions. milestones. quarter begin our will highlights and recent and upcoming an some then we

future forward-looking that statements call regarding performance this of and events note Aldeyra. Please contains the morning’s future conference

planned of expenses timing trial the business other regarding trends, statements include competitive industry future and operations, statements possible market Aldeyra’s of strategies development position, among assumed things. expectations, environment and clinical or plans research, Forward-looking initiations, position, or and commercial sizing, opportunities, and potential results plans, financial growth

based to These upon today. available the company information the statements are

clinical clinical of a patient to have been result As time may affected, COVID-XX trials complete be recruitment the lines availability, and the and negatively our staffing site pandemic, delayed.

to as including COVID-XX the from our potential update the of on statements, those forward-looking Aldeyra materially financial results assumes impact and of company’s position. future these operations projected differ business, Future no circumstances events current actual could statements pandemic obligation in results and the change. and

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

call turn with And that, will over to the Todd. I

Dr. Todd Brady

virtually to have of to Aldeyra, lives. illness. short weeks, want us extend at and every you by devastating affected joining few In been morning I our today. just everyone, to Thank this has our everyone a that thoughts On aspect of Good those touched thank you, Josh. behalf COVID-XX for

crisis. Along encouraging in months, and care attempt for two as they to past to later see past been inspiring the to to want it’s clock working I it’s infection, their and virus solve health discuss our around industry professionals selfless collaboration call. treat across of months other employees over commitment to companies regarding doctors, to extinguish also of been our nurses lines, thank witness the the these will I the the efforts this which the tireless health care global our initiatives COVID-XX this own Over

From Aldeyra’s execute our have to affected orders clinical measures believe other time we although, perspective, objectives. strategic lines, the stay-at-home certain our government-mandated of enrollment we remain and well-positioned on

in marketable morning’s guidance runway we our the As million securities, press cash equivalents noted $XX.X are in release, and updating and concluded XXXX. this projected cash, quarter our into cash with first extend to

On our quarter strategic us call, we disease our prioritization prompted RASP. late-stage quarter including ocular the a in accelerate vitreoretinopathy. to trials Since of of fourth disease dry inhibitor call, programs covalent discussed have and development with programs, conjunctivitis available irreversible proliferative fourth and eye our systemic the pro-inflammatory events two our first-in-class allergic orally disease, our of ADX-XXX,

structural analog of other COVID-XX. compromise COVID-XX to and is activity compromise that patients. syndrome, of which have acute preclincal to reproxalap mechanical patients in applicability forms respiratory potential require intubation respiratory infected the and models, distress release with was First, in to demonstrated In cytokine respiratory ADX-XXX in ADX-XXX lead mitigate thought infected

those X events treatment Second, findings, trial clinical the any recorded ADX-XXX. no in tested. doses positive at trial adverse results ADX-XXX our in we reported and Phase of was April, were from well-tolerated topline the of summarize To

commonly observed placebo, target subjects, reduction were malondialdehyde in that RASP treated concentrations known confirming levels treated pro-inflammatory Clinically suggesting in theoretically subjects relative total RASP to inhibition exceeding observed, RASP described near in was plasma relevant is engagement. the possible of plasma and drug with

disease now the initiative plan success three allergy. syndrome, in the activity ADX-XXX and XXX types disease comprehensive of of X, we release inflammation, systemic to severe autoimmune of embark cytokine assess a Phase With to in on

above data, is strong suggesting X inflammatory a THX broad as evidence, potential preclinical Phase THX, positive THXX-related supported activity Our array reduced demonstrating by across and of cytokines, mentioned levels diseases. that of ADX-XXX

FDA respiratory in the quarter, potentially review potential initiate improving compromise. a has Phase adjunct broad with to inflammatory patient a subjects ADX-XXX thereby trial plan a of other of clinical on the or COVID-XX-associated as Contingent third array levels an reduce to outcomes. compromise we to respiratory and either cytokines, as ADX-XXX, mitigating in therapies agent X single

We diseases. in of to activity test Phase are for year and half also this clinical Xa trials two of allergic autoimmune targeting ADX-XXX the ADX-XXX the second

in The first trials cytokines. autoimmune with THX associated these condition planned and is of patients psoriasis with

inflammatory other planned allergic disease The cytokines. associated in an asthma, with with THX patients atopic trial is

franchise, affects current ocular disease eye requirements and In disease reproxalap. midyear meeting million a by people and our Dry in continues advance conjunctivitis to review addressed the Regarding in for Type filing allergic NDA disease. toward the the approximately FDA reproxalap disease, NDA remaining inadequately to therapies. eye United with have C eye we dry XX States dry scheduled remains at

which of dry review from well-controlled best-in-class and broad onset potentially from plan receipt clinically with our update rapid on improvement. FDA to symptomatic reproxalap, change development plans the eye suggest our include relevant trials, and feedback. Results trials disease clinical We in two baseline following in

INVIGORATE extended later The trial conjunctivitis, XXXX. with now an of allergy expect we first planned, trial delays associated of initially in to from than due Phase timing primarily half completion the allergic X season. For our results is

environment. allergen in INVIGORATE outside chamber many of of of conducted know, you allergy are the avoid trials seasons to pollen As effects like the confounding

ALLEVIATE trial the associated the has the first dry United in for the eye on million success X reproxalap often mechanistic disease. approach new allergic clinical review, patients XX which of importantly, successful decades regulatory potential announced conjunctivitis, to States, and in continued assuming positive and with the be is treatment affects Based last and year Phase

The therapeutic that antihistamines landscape treatment. of to allergic patients, events. studies think of use current corticosteroids. potentially As significant The serious adverse for disease, we as to with restricted shown lead gap unsatisfactory generally of one-third dry eye could conjunctivitis have a corticosteroids fill many chronic are may as is antihistamines and while reproxalap in

due Lack of rare ADX-XXXX in same a We the of and site our primary for cancer. update the and we indications patient trial intraocular time to lines serious time, proliferative clinical plan Phase COVID-XX enrollment to completion prevention has year-end. vitreoretinopathy. are the enrollment ocular availability X for of additional ADX-XXXX, but including delayed GUARD exploring At lymphoma, by staffing

back Josh, I financial that, it will hand cover in With detail. over who results will our to

Joshua Reed

you, Thank Todd.

for from March XX, loss of loss reported For cost the XXXX, year. trials of was compared per the with clinical three quarter $X.XX expenses. $X.XX and the XXXX. quarter net and Aldeyra’s the months ended of research for million, and administrative March development for a last $XX.X general as have compared the a share ended XX, Net resulted million March well XXXX, we programs, with from Losses XX, $X.X period net ended loss as same

the connection in-process also for and primarily manufacturing Research and development preclinical included incurred development XXXX, with of clinical in and XXXX. million the million were the $X.X period period $X.X XXXX Expenses Vision. research March related with and quarter for acquisition $X.X Helio in in development same for ended $X.X expenses to The million the compared million expenses of costs. is the of decreases XX, decrease

in XX, offset $X XX, quarter legal ended compensation stock-based costs, Increases XXXX, flat costs. compared expenses administrative for were General miscellaneous a decrease and the with March XXXX. million March in including other by personnel-related at and were administrative

the million total QX for expenses compared million, total same period operating with expenses of of operating In XXXX, $XX.X were in XXXX. $X.X

X adaptive COVID-XX-associated Phase the and the scheduled respiratory clinical of X ADX-XXX March of and believe fund proliferative Todd XX of marketable sufficient enrollment. million anticipated As Part of cash, for X vitreoretinopathy of current or patient currently XXXX, X XXXX. that FDA to trials noted, the outcome plans, reproxalap, completion on and cash the expenses and marketable atopic the equivalents XXXX, cash clinical trials into asthma subject in as operating operating XX, clinical cash, equivalents were disease, eye and commencement of in will trial INVIGORATE securities on including Phase continuation to of Based X our Phase for the compromise, at March be more the dry additional meeting psoriasis, $XX.X securities we contingent trial mid-year completion of

you Jefferies Virtual Before the that meetings next want be Health Details we know concluding, month section to let posted Media will at Care Investors will hosting our one-on-one and I Conference. website. the and be presenting on of

are look those to participating, you. For investors who meeting with forward we

call over comments. the closing Todd back to Now, will for hand I

Dr. Todd Brady

pipeline Thank you, new that with complements is we our this a comprehensive away program, in ramping inflammatory perspective from disease. Josh. From systemic a that morning’s late-stage key disease are call ocular our initiative take clinical my

safety, X new catalysts a path address potentially bolstered systemic initiative with tolerability disease engagement, about opportunity infection Phase a associated quarters for excited to are potential creates Aldeyra stimulated demonstrating forward COVID-XX coming and by of number ADX-XXX. and the the by and the target we in morbidity The major for data

bringing As with always, therapies that needs. patients plan serious market to efficiently and lives our medical to we on the strategic committed of novel remain improve executing unmet

Dave take Joshua, to that, With I and your happy questions. Operator? will be

Operator

comes question Citi. from Instructions] [Operator Okay. Yigal Nochomovitz from first Your

open. is Your line

Samantha Semenkow

is on Samantha This Yigal. for

me want Can to Just okay? be hear you sure.

Dr. Todd Brady

Yeah. Samantha. clear, Loud and

Samantha Semenkow

Okay.

new you extension, ADX-XXX Okay. into announcement the you runway especially are have I half measures the implemented just of extension that into start studies starting to cost-saving the in with have second this What going XXXX. wanted that three year? to cash factor the given

Dr. Todd Brady

you, Thank Yeah. Samantha.

capital at some is What we trial As pretty frequently look sort standpoint. from at might are our the the looked we the some say contributes time our the of at I over looked of of to of you that, so we infrastructure and and changes expect, think would delays, in given responsible. portfolio of to runway, an addition sort I pace spend that fiscally extension and

in very at ADX-XXX trials think, that I X development are Phase important understand not to respect all. the With to it’s there, expensive

So huge capital a not is drain. this

Samantha Semenkow

sticking what be think these treatment allergy helpful. for indications? would gain you particularly -- And and terms what are of Got it. of -- are duration and to would with we numbers the XXX, envisioning then you what sufficient in and patient in autoimmune proof-of-concept for those studies, or studies should That’s you

Dr. Todd Brady

Great question, Samantha.

And plan from it’s the these year from only our patients to a point, activity Phase or would including the standpoint, biomarker progresses that I XX fair assume as also designs. those a less. demonstrate is At to be standpoint. clinical like not think of Xa XXX, is think idea generally detail studies, but I to this proof-of-concept trial

and for example, cytokine So, mechanical analysis atopic plasma. ventilation profiles an plasma COVID-XX cell asthma, transcription be or clinical psoriasis, would patients to with of cytokines not of interesting RASP in interesting levels In biopsies counts also parameters, from time sputum for example. be but ventilation, in compromise, on only an infected would a respiratory time In inflammatory including biomarker. mechanical in

So these a going I next guide are announce be I are less us the kinds we inflammation, in terms will is of across trials, test will in The to early forward three different idea or kinds those position more comprehensively which hope we envisioning. which of studies X to year. Phase ADX-XXX larger into of think,

Samantha Semenkow

it. very Got helpful. taking question. my Thank for you. Thanks That’s

Operator

question will Chen next from Louise from come The Cantor.

line is Your open.

Carvey Leung

on Louise. This Good Hi. is for morning. Carvey

persist have versus and show Just about you existing do What adapt think What to OpEx others? Thank COVID-XX? the other think in of programs advantages or few trial due there design, XXXX? you And here, Do the a in the -- the think industry can other? from your new you things should of questions the ways in product telemedicine ophthalmology lastly, patients how you. which your how if we differentiates are about asset dry to eye Secondly, several seen. treating here? slowdown competitive

Dr. Todd Brady

call and are that Dave, of to the in on comment ophthalmology to McMullin line? you the initial procedures Why on Great. we eye turn are regarding over I telemedicine the advantages on dry data the seeing Dave the competitive don’t and impact prescribing.

David McMullin

Yeah. Todd. I am here,

eye symptoms disease shown a So to exciting have far and what talk know into That’s ability patients with excited very the in largely we the address number that’s treatments. physician. thus disease. a Reproxalap advantages we are symptom-driven motivates is we to because physician that the and existing has the broadly with because of our reproxalap, go development dry seen versus

motivating health improvements broad And on with see help the assess of But treatment the factor they are as from as management of are because you symptoms. the clinical take doctor. the patient of important reproxalap. So the the a a they eye. we don’t They role the eye sign drives perspective, to front the the day-to-day also signs not in prominent that in

those. And on shown reproxalap rapid has also effect both a of

eye as well and will dry treatment for broadness the that the it’s signs improvement, we of give and rapidity an So symptoms of it’s that so of as reproxalap disease. the believe advantage effect

terms dynamic. the if That’s situation at evolving. patient you on in the obviously something current current of look the marketplace, that that’s do weekly of which happened In the be that on prescribed impact following know been on benefit the We remotely. a doctor very things that basis, we have initially of have is a these they what’s refilled treatments and one easily, can chronic

And chronic two went March these existing on in -- the in fact, prescriptions on disruption of started. up when some the really treatments

in also with how needs can some April, visits. the virtual we we care of do guidance but patients see Now eye through coming seen down, on AAO out that address come professionals have the

very reported study visit by where effectively, really the and you think have you patient And doctor test symptomatology of done. a motivating is the get those a be the things into factor, when in need if you disease, of a in telemedicine will to can the signs that disease eye dry particular

So disease that and more signs on in symptoms, that dry fashion for focus in a appropriate type I allow of a manage telemedicine to would pandemic. the the then an utilize the approach tries would management and out the may of expect leverage system short-term eye the given as more spread the

Dr. Todd Brady

Yeah. And thank Dave. you,

I call a I about just talk turn the to question to over over reiterate to Before to OpEx, couple want -- things. of Josh the

-- dry continue that we symptom is the First believe to profile as disease on is, we said our call, drug best-in-class. of in eye the

that to demonstrates example. would for our like control, think agent I difficult deck, another find we currently therapeutic in that symptom be depicted have corporate it

rigorous second I I clamoring patients not spray. research we are that, thing market to sprays. are think you The want any that nasal is for find say a nasal don’t in will

We a are of a topical dry ocular. syndrome, eye topical agent for relief

due that steroid. which, side potentially And the serious would mentioned is steroid, is effects. we say not the be chronically, as to a Reproxalap the I call, risk second cannot of in not I are a thing used very

best-in-class I think the dry nicely. addition to what and comment late-stage eye me care quite to activity in way, relative positions the novel we action the mechanism profile, is, very in about, over other you let on to to majority of which assets disease turn symptomatic of physicians Josh, to a vast patients plus it reproxalap OpEx. represents So onset rapid of by the what believe

Joshua Reed

Yeah.

that some will talked ADX-XXX. to near-term Just regarding lead OpEx, a slowdown us items that give in the enrollment those catalysts, fund ability and about lower specifically to expenses will to we earlier related

Carvey Leung

you. Thank All Thank right. you Okay. really so That’s much. helpful.

Operator

Instructions] Hong Janney. [Operator comes Esther next Your question from from

Your line is open.

Esther Hong

Good thanks Hi. questions. and morning for my taking

the of assuming So the indications, there moves question and are will Can then, psoriasis you the potential lymphoma? a program of Xa’s to my there discuss successful. which multiple on Is are asthma, primary ADX-XXXX. atopic prioritize potential Thanks. way on intraocular forward, And that that ADX-XXX, streamline programs? how is for Phase you second

Dr. Todd Brady

Thanks, Esther.

different more the activity intent whether the of those those and inflammation, flavors ADX-XXX asthma mechanism inhibition of demonstrate broadly novel indications, both inflammation. as of a diseases is as strength we of have of initiated in program the pursue depends types think, data. asthma represent on we to different of psoriasis I and of terms and In RASP the psoriasis, And

optionality diseases is considerable there forward from in are company that, include children form chronic psoriasis. that signals and or inflammation adolescents. and hepatitis or trials, generated those Examples diseases a disease, I or minimal are that which that clinical in of or related then -- in has cough change THX such renal related think, the In rare that and forward from moving are or cytokine affects of those are allergy diseases different there asthma if THX particular as are terms autoimmune moving may alcoholic

There inflammation relate to kinds that are and THX of many THX diseases.

would experts superb are Xa agree to think in and most asthma study Phase proof-of-concept psoriasis I trials. that indications

mechanisms They our attempting include asthma, I may terms are results, may are that strength but options indications that the in leaving as related activity. and which also depending we diseases open. of to on mentioned, relate in demonstrate But of will to we we pursue the internally, the include psoriasis ultimate

methotrexate, ingredient is uvea active very the the the and indications is which lymphoma, cancer one almost of affects of a use addressable or I rare of are treated is ADX-XXXX. this lymphoma. the is There exclusively which is that generally by intraocular morning, PBR think many that mentioned of for but a with serious Ocular methotrexate of we retina history form ADX-XXXX. long primary

today by make Unfortunately, imagine, drawbacks. treated as own The can eye, which has cancer will of formulation methotrexate for hospitals into compounding up is you pharmacies injection methotrexate. that intravitreal the their many at essentially

intent investigate methotrexate lymphoma. for of formulation novel own ADX-XXXX intravitreal the injection our use So for be would to ocular in

of need and the for months. filing the if And are over question to that exploring would Aldeyra one clinical several is something extent we that’s generate data, any next

So for lymphoma I ocular additional expect regarding us you or two. will ADX-XXXX the next hear more quarter over as from an indication

Esther Hong

you. Thank Great.

Dr. Todd Brady

Thanks, Esther.

Operator

comes next Cross Your Matthew Trading. from from Jones question

Your line is open.

Matthew Cross

thanks Good update. for guys. morning providing the comprehensive and Hey,

first discomfort sign could us a hyperemia as you been Just meeting -- wanted think, couple alone an C for and this what to the this pitch Type there’s bit the discussion another efficacy an competitor as to that X? ask I little space off, in hoping kind of on primary Part on NDA to I a call, just measure about endpoint. the of a submitted using there’s dry secondary guess here, ocular FDA and RENEW give update are you eye at

put of clinical are time will results you schedule, kind a dosing what assessments, fluorescein think to et staining going focusing the or now, that right forward tweaks label? to staining cetera, you best the of on versus and get thinking forward as ocular excuse co-primary the on So frame do nasal me, you insist dryness other usage the FDA potential co-prime, will

Dr. Todd Brady

Matt, a the that’s for in have imagine. been can approval as dry something great signs and be to we FDA deal has about, thinking demonstrated Typically, symptoms required disease. you eye

demonstrated As And a argue the middle with meeting our the you have would two best-in-class we dry have in discuss C we in eye and symtomatic this remaining adequate disease. for clear in agency Type now and of to thus, requirements. control, controlled know, requested scheduling a symptomatic NDA received trials well control we year

required. One signs evidence whether redness. sign, is historically I do I question do as has what kinds not say, any signs I question are are have signs required. a are or will that the agency is One required required, if not think, staining such of particular

The was on other statistical twice significance one recent comment I that run point I that that had was think ocular more sign, I because the primary been required to and happening two what way to a will Phase sponsors terms prior do a trial programs. in achieve of symptom make to missed X on a in in that here. is a if the are clinical end and than and symptom discomfort trials do you referenced case think was

clinical have are will street we reviewed that from going mentioned, with NDA have surprised we and are discussion. the And strength and the meeting meeting. trials on are optimistic confirmed requirements positively we requested We now symptom for otherwise two once have meeting. in Obviously, be updating the eager into we as data, we which FDA wouldn’t we the the of our that feedback remaining to have we

Matthew Cross

it. Got

enrollment trials the around that this and and for more am currently, patients do guess, then anticipate I of of measures for later COVID clinical looking these we third time about in agent frame, to again, in subsides I you in some additional preventative a much kind quarter any kind as I immunity. in beginning that the a due of year. certain in have feedback am need report the time an one I starting the seeing COVID are how of just program shortage of the third concerns frame leading natural geographies to And quarter. had in you Okay. guess, do curious, forward complications, And

of of thoughts the and frame cash program you kind just time So this for any might of kind face? enrollment on that challenges use in

Dr. Todd Brady

shortage in COVID not not mark week representatives any I in government have away, would we Enrollment disease. on predicting is that that and always a with there general can been will go be will the we you, phone agencies patients of agree. a this long-term they tell and of question are

COVID I don’t of have think for the in pipeline yet. as we a panacea

-- I in for room mechanisms always there’s with and novel think are always psoriasis, any asthma agents included. novel inflammatory COVID there disease,

preclinical So lead and the to we to the about evidence -- release ventilation way, respiratory have March requirement by broad-based have reduction, disclosed and at the least cytokine the compromise we press in COVID. which seems in on based for mechanical in that

to syndrome be at is after are for shown can activity, about administered, essentially patients could that be least fact it of orally ADX-XXX, administered via even of the has that in of administered structural can a nasogastric the tube patients we is immediately administered respiratory homolog to after animal potential weaning be on reproxalap, off because hospital discharge. and and which evidence which And models ADX-XXX, clear ventilators acute ventilators are optimistic admission, distress to patients

is days. the hypoxia with patients would at them of our to evidence treat and up as So to stay compromise, involvement which hospital XX about intent enroll and radiographic respiratory through a we pulmonary define admission

with of that predicting have COVID to but think always is plenty don’t or still that are predict, anytime Enrollment, anyone I like there’s Matt, away that soon. to terms think the for been go And you of going room. I is in in very at agents touch agencies, Aldeyra know, difficult we as government

Matthew Cross

guys. great I Okay. new detail and kind all to tend additional and there. agree That’s Thanks, of No. the to programs looking forward these opportunity seeing on progress. the how program Yeah.

Dr. Todd Brady

Yeah.

Operator

I in remarks. Brady to for Dr. call questions back further closing no queue. turn have the I

Dr. Todd Brady

you. Operator. for we and our as look you Thank today, Thank I’d to continue always, you all like update to to forward again thank progress. us you, joining on

Operator

Thank you, everyone. This will today’s conclude conference call.

may now disconnect. You

Aldeyra Therapeutics (ALDX) 10 May 202020 Q1 Earnings call transcript