ARPO - Earnings call transcript Q4 2018

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Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to Aerpio Pharmaceuticals’ Fourth Quarter and Full Year 2018 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Michael Rogers, Aerpio's Chief Financial Officer. Please go ahead, sir.

Michael Rogers

Okay, Demetrius. you. Thank thank Year us XXXX and Quarter Aerpio's for Full and Earnings you morning for joining Fourth Good Call.

year President Executive Joining is me and fourth morning, Joseph Kevin Chief Officer. Chief Medical for the Aerpio -- today XXXX. Steve full Gardner, Officer; This from Aerpio Peters, quarter our on is ended Steve Officer the Chief XX, and Founder; call released December Scientific results Pakola, our Hoffman, and financial

the obligation our not that, Steve? as any With future does time in to projected periodic now or could a complete forward-looking or have if include, therapeutic information, Each about I'd well statements distribution Aerpio to new and of TIME-Xb those and results would you statements announcement limited materially that our to, not its subject be CEO, received to such publicly And planned and Aerpio’s will that of but Aerpio's to and top from these statement and to of potential events you can any at cause of I on description their also release added to in can news including If remind not those clinical over differ you to include events Hoffman. found you Aerpio actual the reports its time the the may with risks so aerpio.com. statement related to forward-looking our uncertainties to from Aerpio. development turn be website product as result page call that statement. like and made the business remarks list, results the the more from undertake like risks Investor update Steve are company's is clinical today trial. Relations A do material on other as forward-looking whether filed line SEC. call candidates, otherwise.

Steve Hoffman

good to was we morning, class complications. and TIME-Xb The AKB-XXXX year study joining double today. TIME-Xb later either improved The of to treatment for study track pipeline mass XXXX pharmaceuticals, or where Mike as designed that top is our to trial in products everyone. severe with of the weeks once month. a twice primary our high. ocular severity or XX of score study retinopathy in continued percentage multi-center us endpoint remain AKB-XXXX TIME-Xb our this randomized We productive very Aerpio patients placebo Thanks, lead a study, daily, advance as receive daily you was XXX activate from patients steps placebo. controlled greater Thank line for and TieX patients XX announce evaluating Xb NPDR Phase were the diseases with moderate results their candidate the of treat to for who by to in two diabetic milligrams first on diabetic

secondary We trial have important. in several endpoints that very are also the

physicians outcome less AKB-XXXX improvement the KOLs, patients as bilateral PDR the these is to such is for proliferative One only population edema also the distinct threatening or its macular but severity disease. to in diabetic assessment key progression practicing NPDR DRSS is a and of treatment – patients and agents, by in have diabetic or of patients bilateral endpoint score, is determine XX with delay eyes most intravitreal next more patient invasive sight retinopathy blindness XX% to complications of and anti-VEGF of and eye administration, the believe or is not have first The advantage that diabetic Preventing we The whether NPDR convenient to allows or patients for the DME. AKB-XXXX can vision and caused retinopathy patients. to XX loss important with complications XX% both administration treating where disease. which systemic fellow of of

option renal October, by improvement of We hoping treatment. provide previously we pleased This retinopathy was renal would a sharing diabetic placebo very AKB-XXXX clinical spanning and Finally, or perspective. patients to of the an the as results from observed At demonstrate of development function present our administered the are of line receiving in in If a AKB-XXXX an next Nephrology of initial coming after the from with TIME-Xb prospectively American complications. update, post-hoc very from TIME-X receiving were analysis in ratio compared UACR XXXX patients hoc the measured TIME-X treatment improvement reproduce of in in that look three in in study. significant reduction TieX the TIME-Xb in showed in earlier only study will our provide to a potential our clinical analysis diabetes, pending albumin activator to this study, and diabetic multiple our a function phase Kidney confirmed X months UACR patients top upcoming forward encouraging this to Society we back we to regarding patients. worsening and data Week to results, steps weeks the creatinin also trial urinary the outcome post systemically

our ocular currently open to for of topical we're advancing glaucoma. in a angle formulation addition program In AKB-XXXX retinopathy, diabetic

in trial will this We and Xb quarter line year top of phase that to announce initiate the of XXXX. the by trial a results end second expect from

$XXX develop provided [indiscernible]. commercialize and ideal develop programs, known exclusive with of partnership, The teens. announced payment terms to up Gossamer We're disease. license and the $XX regulatory experience partnership and to of prior the inflammatory and treatment June sales milestones development, global million company expertise and excited up for AKB-XXXX, immunology Bio and as license the tiered upfront exclusive the million inflammation, Gossamer of Agreement drug, pipeline with bowel royalty given that is this rates believe XXXX, this mid IVD agreement we an very now in our also granted us and this license Gossamer in about of we an GBXXX under potential to the and development Beyond worldwide their in

on joint they've a the GBXXX $X.X committee Gossamer completed and excited to GBXXX we're very with have them, contributes billion of where evaluation. recently IPO steering meaningfully We successful a their as very for development

say XXXX, back that executed all on can we on milestones Looking confidently we of timelines. our and

with to As we we rest plan of move advancing and continuing diabetic XXXX, execution forward AKB-XXXX the our retinopathy. for non-proliferated candidate, our lead on patients

stage for also glaucoma. AKB-XXXX review to Mike I'll We over such back earlier pipeline our for as the open quarter. turn -- of topical advancing to angle to for call forward programs formulation look our the the financials now

Michael Rogers

Steve. results the for and quarter details full financial release year XXXX. Okay. our fourth The earnings Thanks,

So I the release. you for repeat won't what's in written

beyond additional For those what's can results interested, find our be in you on our in which and release press filed later will financial our condition XX-K, operating this details week.

statement, up XXXX. for compared period million same quickly December a the our However, XXXX period couple the common Starting the shareholders XXXX income expenses million, X.X to attributable months were I'll million out X.X ended this the items. take to the XX, for XXXX, in operating was same in point and of million X.X fourth on X.X for three time net loss in to from quarter of

ended and full was full XXXX. to were for million year to year expenses December the common XX.X year XX.X XX, million compared to XX.X XXXX, compared XX, operating loss stockholders full for ended ended For million net the million XX.X December XXXX XXXX the attributable XX, December in

million with our TIME-Xb of expenses by trial, million million Gossamer. balance decrease XX% $XX.X as $XX X.X and XXXX So million increase million December XXXX expenses consequence XX, with debt. million we known upfront in the expenses personnel operating a One from on or XX.X an cash AKB-XXXX, the in attributable the by and as of candidate from and to pipeline approximately our in million XXXX. payment $XX candidate administrative XXXX year-over-year, deal and approximately General this lead X.X primarily And approximate despite loss of as the to GBXXX, million. AKB-XXXX, quick XX.X primarily received offset ended as agreement many was our spending million the recorded Steve increased to was for GBXXX. call December increase Gossamer net for year for by license on XX in this as X.X in mentioned the reduction we related sheet, and partially our year a increased a part XX% period. note during you had development to spending the which as on ended million versus XX.X full for have increased of license in revenue attributable expenses is result or now This was no XX, the XXXX Research our XX.X position on we was and XXXX at December know,

questions. the So for that the there? are Demetrius, We’ll you financial now open the concludes quarter. for summary call

Operator

Instructions] first Cantor question [Operator our And Fitzgerald. with from Merle comes Eliana

Eliana Merle

viewed study, terms to to of would treated the meaningful? clinically analysis, what PDR the difference be guess the mentioned that looking as at more what secondary in group baseline you leg progression [ph] in And progression expect is guess, the PDR, to So the I would progression placebo? TIME-Xb I in upcoming PDR the rate you from

Steve Hoffman

ask to Pakola to one. Dr. I’m that handle going

Steve Pakola

the Sure. question. Great. great Ellie. Good Thanks for morning,

have. stage severity surprisingly, baseline this, patients not retinopathy So depends diabetic that the on of

have each actually XX% various XX% But DME, of in a a vision you would at that to XX% mix that baseline roughly one salt with studies to we in that looking can natural moderate time the If, we span mentioned and at complications of developing in because a severe we're care we roughly XX%, severe a anticipate study, just patients please look DME severe developing XX% year different. at NPDR end and about So NPDR. grain PDR, study might of severe what history and recall this patients develop you we have timeframe. is do anticipate within NPDR of macular mix diabetic over we moderate edema spectrum, course, we study, where looking to take that PDR at gauge example, also PDR this the have of over to of patients for this very the to studies and moderate and threatening

why you that's So into baseline take have account really characteristics. the to

we question, XX%, at the endpoint half To trial. of combine think we would might what of threatening you is treated it's meaningful? be second option complications anywhere speaking, occur anti-VEGF, back disease. this but we'd at mind what clinically specialists stage that waiting. at not of treat NPDR, and expect repeated in kind those, envelope of When of eye, year, the your to retina If keep the who watchful with to at at vision when currently generally severe to the reduction and stage in the disease, are to injection think treat of There looking one what being these that's patients patients from XX% really of roughly we the speak this which moderate is to

is one a they these blinding potentially high these even going key year and conditions. it's patients that doctors issue really So their these proportion to for know of progress time, over patients are to a within

ask So be reduction them asked when Ellie reduction what any meaningful, say frankly. of question we clinically you that would they very just

Eliana Merle

Thanks. you're you'll And the that mentioned Thanks. on I what that us through Can of sort I helpful. then That's guess the the be before have getting? guess exactly data to you in program, what end we you data. year. will see just of data walk hoping And glaucoma

Steve Hoffman

that too, Steve, and ahead take go please. one

Steve Pakola

Sure.

formulation. X first-in-human ocular study So keep with the this in phase topical mind, a is

since on However, relevant testing, the pharmacodynamic opportunity measurement, endpoint. phase for is to that have already in human first X measure, where at have in non-invasive effect an an pressure, look of it intraocular we the clinically IOP a pharmacodynamic indication we phase objective

population study. “healthy selecting yet normal first also somewhat to So above would but IOP, population but It we of healthy in plan volunteers” hypertensive These who that a take are or do be have happen glaucoma going enrich human including this to volunteers we first traditional to are ocular the system. not we generally by patient in a that. advantage volunteer study, is

greater potential dose and a will regimens this IOP So different a doses see phase study. lowering X look at greater in us or we effect the that would to sensitivity at a that likelihood give

assessment we end at and will period can the of So diurnal so it's on at diurnal really looking baseline, pre-treatment from the chain that baseline IOP. that treatment advantage on those changes kind at measurement baseline a IOP measures least traditional from IOP take multi-day of basis have also a at dosing we traditional of of and

Operator

And our with from next Aschoff question National comes Jonathan Securities.

Jonathan Aschoff

wondering XXXX So forward for for looking Xb I and your the showed I'm if that was OAG formulation systemic NPDR, I no was if topical phase and about to benefits. only data could if you thinking formulation develop sure. TIME-Xb for But possibly

Steve Hoffman

kinds in of Schlemm's we've topical topical the it Well, of Canal drug sufficient get those we levels gets of back formulation don't a track tested just lot we've eye, primary front – for believe. treat a the of XXXX conditions the the models eye is retinal of doesn't the historically, of to of the and where and But formulation drugs outflow which angiogenesis animal to are.

in So more were sufficient we're drug to of the enough retina, use vasculature not action indications. most levels back that high side on animal with the data popular much getting eye, the getting of in the levels drug confident glaucoma to successful we to of in based administration the

Operator

our question And Adnan comes with Butt from Securities. next Guggenheim

Adnan Butt

release. assume, first questions. the in -- top -- the how I will course, the for is secondary part of how of Good endpoints UACR, much be on I many the will you to endpoint morning release? the will be upcoming of that a VTCs put able Xb line? thanks of at be the out and primary the My mean,

Steve Hoffman

Well, data primary, primary changing might additional and include, line study around changes from progress top right percentage of to patients some fellow secondary eye eye, data the release the There talking that we that endpoints baseline. the the the for ZME would will UACR are and and we planning that now, to be and but those PDR be we’re about. DRSS

Adnan Butt

do is medical you or to positive? time, at data any a meeting this placeholder the present where at it's Steve, expect assuming And Okay. there

Steve Hoffman

can Steve one? Pakola, you Again, answer that

Steve Pakola

for forum both and with our are in forum. the There Yeah. We're the Good on Thanks advisors the meetings specifically usual questions. active Adnan. the morning, in discussions that. retina the year ophthalmology throughout

to the present program. we we're we but to meetings, on will more eye our the next able key at So will able about confident we keeping a on say that feel be that, close at be update

Adnan Butt

there the be on so continues more the over contents multiple wondering you far, report on top the been time for any has able One And time. data, that points. improve release will I'm to to series so line, result time if,

Steve Hoffman

Steve?

Steve Pakola

Yeah.

look not we time related only the of weeks So, the do of of treatment. one point at that's that we'll XX treatment, the what at course that aspects what end if see over but definitely of estimate is

what the as reviewed top at at press the what in results You sometime and terms Stephen looking disclose can look this just at line of far release to as we'd be month.

component the as more doing Of weeks the the and course, we'd you be lot that, know, of top data. line is overall a after a the of just in picture cuts

Adnan Butt

And to around questions few to formulation. develop the done form of feasible work if Steve. a any company wanted has I on there's acting the or it's XXXX long been ask that? Okay, topical if a

Steve Hoffman

Well, is to more patients be we’ve drug possible. a recognized formulation have for one that that convenient administer the less frequently as going as to

think can twice if XXXX sustained a opposed as working need we day, a to that day we twice get we at of least once So down to a on formulations are day. release at,

Phosphatase, one a put of we're sustained make on And on And XXXX working per once a these But release challenging. seems a activation the XXXX getting a to effect inhibiting about in we investors, Protein to emphasis that by the to some to our quite appears physical the that animal pen pharmacology, like but monoclonal on extra-cellular much Again, be then day. components the talk have hopefully XXXX same monoclonal cell our when intra-cellular we we'll and domain. products we get vascular to So phosphatase. working which does once And formulations. always also speak week. pipeline endothelial block on early it TieX XXXX, longer the to the binding antibody domain with chemistry of don't of that's humanized of formulation that is Tyrosine

indications. XXXX. XXXX would And an of benefits to programs a kind our same one administration into four antibody three we So, be would positive every weeks with these subcutaneous data development management of accelerate of to achieve hopefully lifecycle the to be that once of could with

that But convenience. solution formulation. to to term might the is it’s that’s So recognize to We think get be working a for once-a-week we the think that we best to possible important. Admittedly, hard get once-a-day formulation. going antibody for the a years We're convenience to road. patient several long the be patient down

Adnan Butt

last the one one you Just cash the did on you? long numbers, will last say to how current

Michael Rogers

set first quarter. And what the that least till through XXXX of said XXXX. into and cash we've now. have believe We We that's second the into will cash go last quarter will up at

Operator

Needham from & comes Messer question Chad next Company. with our And

Unidentified Analyst

This Hello. is Chad. for John

question about positive, in any of study out who reads Just patients a clinical kind it data, kidney be are with would of the moving would diabetic, data what forward -- with population, if in UACR symptoms? have the disease think that you don't ocular

Steve Hoffman

not of or trial. diabetic XX that. would have right to that planned look like a exclusively But study but design we nephropathy design, now, study our and refine to but we only GFR the months, irrespective in course doing that kidney or whether timeline and UACR, clear again we don't now, to the CKD we think Phase chronic course class or class X right diabetic a disease, action the and do scenario now, X disease. retina objective in with refine, planning be still to best are but we that of trial do need around patients next at And be nephropathy area, right would class lot over something be X So that for X, we X would there possibly of the that a to of need their affect we in can

Unidentified Analyst

about a similar these endpoints? [indiscernible] they looking were are I time to of the events progression, talked for that so study bit in know and at you a a clarification, Just PANORAMA

Steve Hoffman

Pakola? Dr.

Steve Pakola

in Great they on the question terminology, so, are. fact,

threatening refer these when when So same progression in the to PANORAMA complications. severe. severe or study I to complications We're And refer is of or moderate in they progression moderately PDR, a saw vision basically the vision releases, they releases, in events baseline threatening patients recall those the to of severe PANORAMA the looking to, at or When of studies, the from spectrum, as considering progress importance PDR. discuss more to And DME complications. severe. you'll DME to at looking they vision either threatening of characteristics, that's XX% end to words, other their

Unidentified Analyst

the much forward very all appreciate and TIME-Xb clarifications I looking Great. the data. we're to

Operator

next with Chen from our And question Yi comes Wainwright. H.C.

Yi Chen

My first positive, data with would the pursue Phase a by yourself question are is assuming the potential TIME-Xb or partner? X you program

Steve Hoffman

Right population as we're that that own. our Well, and will And primarily that for be population own. NPDR prescribing interface and believe a we to point the now, question. TIME-X a on call retinal specialists that small tackle progress thanks planning think patient the on our for X We that's we can XXXX ophthalmologists. company

So going be we're to that. primarily focused on

there course, nephrologists, primary diabetologists, from and are identifying patients these optometrists. endocrinologist, a of in Of care referring other involved lot parties physicians,

future, at the can focusing that the the may think our in on in initial partner NPDR ophthalmology on that own. commercial with we to the setting, reach, have a we but point want and So some launch for we broader a populations tackle

Yi Chen

do receive XXXX from and to any and to have second program expect XXXX? My whether development is, you this happen development GBXXX on milestone any update the timeline in you of for question

Steve Hoffman

be to and can we can't Xb seems development we'll well. What studies the going a they that's Gossamer. it they're because multiple on that this some Well, I had on formulation to to is what public a company, announcing dose to we we patients really IPD going we is hard very spring, the going study can we're hopeful doing go They're in into now in really working so be comment that They’re in be have that on phase the in that when hands have can't their share of year. say control. development But and data. sending say, the news they're initiated continued of GBXXX

We it first payment half Our expect should first come it happen to early this the don't milestone them year. happen XXXX. year. in of from But not until will probably next

Operator

call closing and this you. of Stephen today’s for over Thank to our concludes to any gentlemen, Ladies now Dr. Q&A turn remarks. like now portion I conference. back the would Hoffman

Steve Hoffman

for forward of month. you look from Thank in you much study Thanks morning's have all participating very again results and thanks top this We to TIME-Xb day. this later the again call. with and a sharing great line

Operator

program today’s Ladies all and for thank may gentlemen, disconnect. conferences. day. have Everyone, the you conclude and attending you This great a does

Aadi Bioscience (AADI) 5 Mar 192018 Q4 Earnings call transcript