ALDX - Earnings call transcript Q2 2020 | Aldeyra Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Aldeyra Therapeutics Second Quarter 2020 Financial Results Conference Call. [Operator Instructions]. I would now like to introduce the company's Chief Financial Officer, Mr. Josh Reed -- Mr. Joshua Reed. you. Thank

begin. may You

Joshua Reed

good and morning, you, everyone. Thank

take an call President and the Chief Officer. begin with and recent David me Aldeyra Brady, Commercial with conference and I we'll call Aldeyra. statements future will discuss events Brady contains Todd Dr. future and Dr. will of note performance Chief Please milestones. second quarter upcoming our forward-looking our questions. clinical results, highlights are McMullin, On overview Executive and Officer; that the of financial our then your this morning's regarding

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

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

company's Todd the XX, the results that morning I'll June call with Officer. press and to this described our turn cause Chief release And Dr. materially XXXX, ended Brady, company's for to Executive and with factors greater quarter financial statements concerning the SEC. our in President could results containing information over that, in Additional are differ filings the forward-looking detail the from issued

Todd Brady

Joshua, good morning, everyone. Thank you, and

COVID-XX. reducing second we tier pathway for assay the The of industry with the to by eye The submission and the of The for endpoint confident especially has the to RASP are of disease. current made also for fourth in spread a eye patients the is the COVID finalization testing of other safety we subject From this a tragic a of their seemingly Species clinical preliminary therapies patients FDA, timing work results treated quarter in is, the our potential end pipeline medicines by expect not RASP, in NDA health topical industry thoughts an XXXX target to those hopeful year, culminated our subsequent to adequately course, in public trial our century, development disease, NDA mission, trial of quarter, I, fourth dry are standard signs our dry C disease and by first with in by year. the ocular clinical together sign levels and reproxalap virulent for clinical the responders planned end objective study which Type to RASP of the of due the in disruptions immunological of thank plan expected developing and agreement XX. working want Initiation of being extinguish the and meeting our novel of our defeat again, our surreal remain XXXX. to to the continue disease. the the health to to submission an develop dry is the diseases dedication coronavirus design, team abilities affected activity year, to Reactive development As use to topical for Aldehyde necessary levels of or improve eye conditions as whose objective In care evaluation. and ocular and but quarter the lives clinical assess an with reproxalap of initiate perspective, reproxalap, we therapeutic of worst remaining and of the care. key the crisis meeting in was charted first-in-class to relentless

Our as tears is an data eye which of the IIa objective treatment. Phase RASP our disease XX for by tear of sign optimism dry measured ELISA RASP -- trial use levels days diminished from by RASP of in treatment reproxalap following successful supported in of as

XX also shortest X days. RASP duration the For is dosing duration X the under consideration of trials, upcoming dosing the days, longest is to whereas

reproxalap of and RASP and RASP forward be which Additionally, trials look of with been addition in patients on of perspective, acute observed additional RASP the significant of be X,XXX designs a has already other the sharing in FDA than evaluated upcoming safety requirement ocular eye reproxalap trial could disease, the across options include dryness affects number safety, will effect reproxalap United that to trials clinical validation providing dry In following dry States. an of We'll details shortly. million more signs than clinically XX the measure the symptoms numerous From for and no more in suggest activity changes limited safety consistency assay and important and topical eye the to to protocol concerns. assessment short, a chamber therapeutic disease. patients

Union to to receiving approval, the the product trial many the designation of designation X,XXX Japan medicinal XX combined. patients the as vitreoretinopathy. European surgery, per is ADX-XXXX XXXX, retinal proprietary quarter trial Phase in in being from market are roughly expected allergen ADX in are and chamber III granted opening orphan is as conjunctivitis programs assistance, years evaluated leading of year funding upon for product novel ocular the affecting of injection of Commission treatment the proliferative the a and first protocol second States orphan GUARD and EU in exclusivity. rare medicinal methotrexate other of intravitreal Top area year, research and but our market United results sight-threatening disease of PVR eligible failure allergic retinal pipeline. detachment, Phase the the for and in our in retinal Europe line new of this In the XXXX. drugs in for condition III reproxalap the a INVIGORATE at ADX-XXXX nearly twice Looking cause European detachment in half opportunity

given an year. site of Given and by delays expect PVR the COVID-XX, the caused to of by slow, the we clinical been with although nature the of has end provide progress you GUARD this update

PVR, a or of rare, the you primary and and new FDA. of approved is subject therapy drug As clinical has also designations is many program fast ADX-XXXX our from there people track care the for and that orphan X,XXX States with received know, injected although no affects about been no PVRL, pharmacy-compounded vitreoretinopathy cancer that lymphoma in has annually. the eye. for standard approximately of are diagnosed treatments United new into XXX the the methotrexate is disease, high-grade approved the ADX-XXXX cases aggressive There

for We PVRL. designation ADX-XXXX for have in orphan filed recently drug

Turning to systemic our disease programs.

for trials which been this The We is of development of investigator-sponsored anti-inflammatory to the has filed anti-inflammatory data FDA An the marking psoriasis, of clinical and systems combination, time that assessed In of also in COVID-XX, autoimmune excited and with about inhibitor, in the year, testing knowledge action. disease. systemic an very the been the mechanism are RASP and to potential which key available first immune disease; inhibition modulating represent cover RASP II cancer. milestone immunological asthma, ADX-XXXX, In Switching enrollment atopic the have ADX-XXX, states. ADX-XXX novel psoriasis XXX of has an Phase new quarter our characterize novel clinical RASP inhibitors cytokine inhibitor. storm, represents the including RASP IND we asthma the suggests first ovarian of Il-XX. states in systemically ADX-XXX been exciting EUDARIO reduction and to development syndrome the testing order interferon fourth an alpha, while initiate and cytokine, to inhibition activity model demonstrated may II to clinical compromise. of ADX release completed a Clinical significant respiratory to highly modulate patients and year. generally. of animal expect gamma an immune COVID-XX pro-inflammatory allergic to prevent expected with of results TNF and begin trial in Phase the The has statistically with cytokine cytokine HSPXX in ADX-XXX the the broad In is in trials switches, in more this IL-XX clinically, inflammation, which our trial upregulating gamut levels, will this in from

by Regarding position, ADX-XXXX financial the our raised stock will proceeds approximately X We request of to additional funds: against in and the evaluate ADX-XXXX feedback, completing preclinical XXXX. program. Institute which update previously be causes National We recent of with of the program announced accepted Perceptive third COVID-XX, a FDA by the with approached Partners. the antiviral care-focused gross our quarter COVID-XX the million, has COVID sales consistent midpoint strong plan offering in transactions infectious in-vivo models. Allergy on our Diseases, $XX.X ADX-XXXX These the program, performed virus of ADX-XXXX at-the-market Avidity common flexibility to testing that health Advisors of and end enhancing to SARS-CoV-X,

to disease We conjunctivitis. our be including sufficient allergic dry expect and to potential cash operations runway fund approvals eye in reproxalap through XXXX,

like financial the I'd to Now review. turn back with to call for Josh the that, over

Joshua Reed

Todd. Thanks,

XXXX. to a and quarter with second with costs. of clinical costs. XXXX. expenses trials $X.X compensation total Losses for $X.XX cost XXXX. were XX, for manufacturing for other decrease General for the miscellaneous same the loss $X.X June ended million primarily operating from we XXXX. with the and development, the were the expenses. $XX.X a a the in well operating have Net with development $X.X expenses administrative of as development $X.X clinical million the million period $XX.X of in period For administrative for XXXX quarter compared for personnel million XXXX, related net quarter June decrease and administrative were same for compared net general XX, and period loss compared of same the million The and $XX.X due XXXX XX, million to the million reduction quarter per and same the expenses million in million ended expenses of ended costs, lower ended XXXX, including is share programs and preclinical total XX, and with period resulted $X.X XXXX loss as compared of for June XX, Research The XXXX. personnel-related stock-based was from $X.XX research in the ended in compared quarter is reported $X.X $XXX,XXX In of June quarter June

sufficient XXXX, Avidity Perceptive As Partners and program were in to equivalents sales offering potential cash marketable XX, and NDA orally-administered of eye of ADX-XXX securities million. $XX.X June the Use cash at-the-market cash, the to in June of in approvals million of from $XX.X allergic Advisors, was XX, reproxalap received XXXX, clinical expected be Subsequent and positive include cash XXXX, plans, submissions, marketable at-the-market securities end are through equivalents to NDA investors. conjunctivitis, offering continuation XX, clinical and securities PVR other equivalents to as the approvals. proceeds also operations II and including testing plus of inflammatory cash, and inhibitor of fund additional marketable the Based trial cash, current of III June cash are program acceptances for assuming on operating Phase XXXX, dry diseases. planned disease and results trial GUARD Part to I Phase and in and RASP expected

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

Todd Brady

Josh. Thanks,

and of second ocular executing systemic on of across milestones XXXX a number clinical development strategy have forward and to for programs. the our look our half We planned

Looking at calendar. IR our

and the at connect presenting forward look be Presentations events. with Please PacGrow Conference. Biotechnology will Healthcare and and details. or Virtual these be We we'll webcast. section other always the week, events Virtual hope our meeting for Events website to check Wedbush BTIG These Conference investors to Next at you with of upcoming

with committed plan lives take As medical Dave bringing novel on the needs. therapies unmet your market to I and questions. executing strategic With happy patients always, that we be serious and efficiently will to improve our that, to Josh, remain Operator? of

Operator

[Operator Instructions].

comes Cantor. Chen from with the question Louise line of First

Louise Chen

disease there's gone? How for of been sign enrollment my the the clinical COVID. give trials for in is you a is, could are of had recognition And means to that landscape And how trials the potential terms Can you here which more COVID? impacted in may for you into has evolving you last on your I adaptive dry approval FDA's you significant and eye detail light constantly first due the color that was be opportunity? I what then progression then is on question headwinds of for then RASP So here? of COVID treatment to trial more and for you And on those some market noted question trials. as second get have question

Todd Brady

represents no truly which company your transformative was the The RASP target questions. years has upon knowledge, eye disease, diseases. founded addressed to probably is many, ever anti-inflammatory ago. for development a pharmaceutical that many applies diseases ocular Aldeyra. therapeutically for RASP. many And thanks not as yet, is To dry diseases, company broad-based excellent RASP only RASP but very Louise, such systemic also the approach our

to inhibition that of were covalently as likely eye RASP. the objective based reasons, practically regarding disease, to clinical to that an reproxalap work it thrilled you be ongoing start that is those inflammatory inhibitors the compounds our RASP about is an RASP direct of trials These FDA's classify should to we What the all and decision dry other RASP RASP. bind for the which, So company are about means sign as of mechanism know, the assessment condition. of on fact for the the is

we're this the believe vivo. fluid file eye have year administered patients what NDA we chemical we'll of have position previously be announced. is reproxalap. that a leads And in an really been that in that as measuring dry case, for next So disease in reaction a us to to And tear all in

for Regarding we COVID both enrolling the anticipate trial XX approximately patients. designs, programs

likely to not we included point, X:X drug randomization placebo. this I think At have adaptive there'll designs. be a

our there for determine that will clinical significant positive preliminary here. going of I outputs have I filed IND Enrollment pipeline nature peak back during been think May is vision happened simply March, we by The have PVR. III the the that as has and be mentioned testing, results despite to these from patients the is was many results so COVID-XX has coming Phase XXX, help the What which forth the started. mentioned, today, in NIAID, trial, XXXX into were first been on further despite The to of in cases changes, one NIAID's trials for Guard The GUARD trial behalf. much the affected if the COVID that not obviously seemed by more losing number us significant. April, trial, call the you in-vivo difficult, case, of hasn't subsequent for impact, you be has COVID a have in if sight. in COVID of and The time were clinical know, that simply our absolutely thrilled coming frame. did on during not industry sites, as Such the is to in to staff, subject performed the was And across that not some test research patients investigation to diminished non-essential. about as is that we're of our in was which impossible, decision being considered Louise, enroll furthermore, many it while cases, been patients. ADX-XXXX are hospital

the The affected with number was in peak the allergy pipeline, The is, regarding to Phase However, rest of of we spring. during terms the program of news pollen. in seem the program, do cases FDA on the under planned III a enrollment. been because good be hold overtly the not program discussion largely allergy the dry COVID by was eye of

we As pollen, cannot Amb know, INVIGORATE you in to the enroll with you fall. and expect reinitiate programs allergy again program the and

we were of our relative terms in fortunate impact to COVID. programs regard timing So clinical quite of to with other the

Operator

Instructions]. [Operator

with from comes Kim next of line question & Co. Oppenheimer Justin Your the

Justin Kim

talk a versus labeling Can trial acute from days, the time an as establishing think of about perspective? early this some it's eye, observation appropriate a on progress. a be disease the activity. about know but assess behind investors little had on points perspective dry action X-week rationale discussion you and reproxalap we've would on I perspective, what with duration RASP Congrats as of you sign to bit just the

Todd Brady

X our levels days in this As few the anywhere trials a X subchronic ways RASP was that my spend chronic morning, to end when some RASP RASP And RASP that reproxalap, of corporate bind I are is so-called as generate RASP RASP on antibodies want range duration of free to is antibodies RASP RASP you significant highlighted know, assay. ELISA the comments That XX different the I proteins. X days ELISA. then there two detection talking our and by is the showing XX The and reflects bound we're trial. against form as bound why to antibodies, the from an sort RASP. are statistically exists seconds after to forms, body which potential able measure in measured in about that dosing reduction a highly on of or in self-protein. The around proteins, the of acute proteins. is in the bound more end, to RASP to for that that administration measures ELISA to floating IIa they're cases, Phase antigenic data reason days deck to in to antibody-mediated

So accumulate the to generally levels. which bound RASP RASP the IIa study the we ELISA in ELISA why measures assess bound RASP, use XX over and days, time, over Phase is

the end X techniques day we because LCMS, to would RASP there, X On that assessing spec dosing. dosing or as change acutely RASP think we'd looking the such of following free mass reproxalap, levels be might other that more spectrum, at to regarding be of acute relevant

X and technique shortly. paradigms begin studies first we techniques, those for end of and assay protocol of within design dosing precise ranges X to different RASP up will somewhere then So validating the those the establishing the

Justin Kim

of And whether of with Okay. to regimens the disease just BID you think about Great. that to sort eventually? do on maybe have conversations the investigated? sort to be appreciate do dosing you it. be or have tapering you you'd QID And Got had then, how in state would FDA

Todd Brady

dry clinical I that signs. I that wonder think most regimens? I question, what of case dosing use duration to back signs physicians part the I milestones. up all, eye and think Patients first what either morning milestones. gets dry primarily, and is. in are the in first forth. disease, my not of it's diseases, disease signs test of my and are or Instead, of First of that community wonder view is as do regulatory I believe thinking, patients worried regulatory about or signs, particularly how perceive And corneal the and so including your we not do the patients wake stain and Schirmer's eye might Right. certainly foremost, physicians dosing

the So In to a purely for paradigm, this to important. X you're day a I with dosing less -- trials for dose case, the dosing X of paradigm signs, is lot think, associated X X -- thinking limited of number doses. day

QID, the XX-day dose the the December. of III release with would dosing paradigm, For dosing first phase induction was which back we maintenance Phase the would established which RENEW trial I in expect is of paradigm, our

weeks In patients, induction how general terms at reproxalap physicians with and think dosing in paradigm and label treating RENEW XX really the over the terms how a I maintenance of that is for and paradigm be sets QID the followed used, the dosing space. tone look drug established dosing the BID that by of in for the for maintenance more initially, will precisely

Justin Kim

filing? be later, paused. Okay. That's in year. know by NDA know dry clarification it says filing I question. Maybe with I release, Is thinking the that current press going that of it Just be onward end continue to a going it next the is says to also the concurrent -- there's a to still just really helpful. the eye

that is expect expectation them together still. the would if you wondering Just

Todd Brady

current and the that the both filed for continue The of eye concurrent dry those this a for part and together, really the can specifically as that the do the line paradigm, eye year as be complain suggest studies, next studies, conjunctivitis the compound latter NDA strategy. conjunctivitis overlap the we guide itching, allergic the to a that ocular the advantageous, to see to time overlap conjunctivitis positive treat be NDA. for of of eye of will how pending lines time diseases on between about because highly with to allergic NDA, over disease overlap, allergic course, a data, patients out to of about the not allergic however, well. single seem and half point. seems efficacy and for at is complain filing both possibility or that We with the And all It early we'll disease part out Our diseases disease turns only such physicians, of patients perhaps of eye course. this also could of about have like NDA that half concurrent play before dry of both patients the clinical best but safety events thinking indicated XX% dry would overlap. concurrent conjunctivitis. dryness. year of regulatory a dry There and Would to But be is

Justin Kim

sense. Right. size makes last the the what study, it? for and would of anticipate as for is just patients on lot Great. well you That is an question as a there of My safety expectation number scope, duration

Todd Brady

Right.

X dry requires patients year For current complete the dosing. eye XXX is my disease, of FDA that understanding generally

on believe based we file we the months safety X sponsors' interactions based of other agency, can data. However, on that with

fairly So what months. mentioned comments, that disease. safety I such tested more patients. the is They'll are they XX most over than I X,XXX happens will to XXX standard eye completers over-enroll. in begin we've at XXX in prepared patients well knowledge, that my will our dry as trials have say, And with sponsors

any far. safety dosing signals safety no no any patient received or no in other seen suggest in corneal would have retinal with We aberrant drug that so changes issue been there findings, findings an reproxalap no signals, that has that's intraocular pressure,

Operator

at there further no Dr. turn questions are for to over time. back closing this Brady I the And will remarks. call

Todd Brady

today. us joining for again all you thank Well,

forward progress. a we nice our you. to updated day. keeping you Have always, Thank on look As

Operator

your you thank ladies participation today's We you, please that That and your ask you and disconnect does conclude gentlemen. Thank call. conference for lines.

Aldeyra Therapeutics (ALDX) 9 Aug 202020 Q2 Earnings call transcript