ISEE - Earnings call transcript Q2 2020

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Operator

Good day and welcome to the IVERIC bio Second Quarter 2020 Results Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Kathy Galante. Please go ahead.

Kathy Galante

Good morning and welcome to IVERIC bio’s conference call. is today bio IVERIC Mr. Representing Executive Glenn President; and Sblendorio, Chief Dr. Officer Executive Chairman; Guyer, Mr. David Financial Dave Dr. Carroll, Officer; Chief Pravin Strategy Dugel, Chief and Business Dr. Officer; Chief Rezaei, Medical Dr. Kourous Officer; Abraham Chief Scientific and Scaria, Officer; Mr. Officer. Keith Chief Operating Westby, development intended potential research cash development our the balances; and the our the Zimura HtraX evaluating the activity of our of candidates Phase and today product our previously to on and and would our of evaluating treatment cash hypothesis of development pandemic and Xb we and other expectations to I a financial the the practices expectations our and our bio’s the of regarding Disease, regarding the Zimura development regulatory COVID-XX market clinical clinical for GATHERX research expectations treat; the trial; development treatment second the other mechanism trials; clinical on for a retinal use and treatment provision conduct financial geographic future and for and of inhibition and potentially treatment remind and and for the X potential results other position and regarding matters, to you including expectations complement Phase IVERIC will making of of to retinal timing, X product our our indications the statements programs, trial use for Zimura the size statements of and utility candidates, development strategy. clinical Zimura atrophy; as action like treating operations GATHERX, of atrophy be the relating potential and and business progress trial our strategy research our operational, our projected that announced product the trials impact for including for information; of Phase recessive autosomal clinical Stargardt atrophy geographic geographic diseases; regulatory and trials potential are of Zimura, of of and candidates; These Securities safe purpose for forward-looking of the under Private Reform statements Litigation of statements XXXX. the constitute the Act harbor provision cover development many risks results and from progression to subject that other to research are for for any collaborators of statement, development COVID-XX of university and clinical and progress and consummation including various these additional trials; the risks. the need from programs, and data our development could of operations statements materially These programs matters the initiation those contact availability and regulatory research future and third-parties; its matters; impact and financing risks business events negotiation; expressed cause forward-looking expectations capabilities; organizations, that and and programs; reliance relating and manufacturing financial position; in other and actual differ to on of establishment development manufacturing on pandemic transactions of in included filings June the for XX, to of our business. I the our factors X-K affecting report on Form Risk in and XXXX, risk SEC our a description Factors refer you quarterly to particular filed on detailed

date. today In addition, relied only be represent subsequent of statements representing and upon our of should as our as any forward-looking views as any view not

future, elect I to these the turn now any at do would statements as may the update over to except disclaim point law. we by in While so, forward-looking Glenn. call required to we some obligation

Glenn Sblendorio

we our everyone And appreciate Thanks morning. this you Kathy. good morning joining thank for call and

continue we families times. very and you your hope are and challenging to these navigate I through safe First, healthy as

achieved the Here quarter. with second are very at the have execution pleased level we we IVERIC of during

announced In from months another positive June We major milestone results XX we are GATHERX. to Zimura. thrilled with have reached

indicated macular The GA, an of since treatment degeneration this GATHERX initiated for with We secondary X the represents the continuous trials from favorable XX to suppression Our therapy. GA, for months. results to impressive currently from Phase GATHER enrollment benefits continuous is achievement showing Zimura our age-related patient is secondary GA geographic atrophy The first Zimura clinical trial of Zimura AMD. Phase AMD. patients, we Phase treatment inhibitor think in trials GATHERX complement X Shortly GATHERX X for the believe for for GA safety of secondary with GA’s novel or following growth for AMD. to to second acronym treatment clinical clinical GATHERX, treatment X positive Zimura clinical profile only CX trial we or in a a Phase XX-month the the results

US Our to month recruitment primary at endpoint to another step main for Drug retention The enrollment in we GATHERX trial. of which aggressively with drive us the patient is approval safely clinical the priority delivering and brings European intend file to Administration Food Agency. XX clinical achieved closer patient Medicines is patients GATHERX and currently therapy of and potentially in Zimura, treatment. the meaningful to Initiation

secondary designation GA We of continue AMD. for and FDA for to Track work are treatment closely the receive the pleased Fast with we to Zimura to FDA

In multiple early AMD. role of of upregulation inhibitor IC-XXX well potentially be have addition Zimura high there was X believe another molecule to We could vet. our potential peptidase the target in advanced, temperature in factor Stargardt's small call AMD. HtraX pipeline. strong in We as is We support we HtraX been dry that a as of HtraX implicated requirement treatment is intermediate promising or in A and a what treating compound this protein data, based AMD. has complement disease, development the risk believe, form the in believe a important dry role serine development program rationale that scientific GA to systems impactful of may on strong Zimura and the AMD AMD in scientific as in

top encouraged our target priority. is FDA We AMD in both IND Zimura GA preclinical current to to are early the planning IC-XXX’s extra submit to to Based are and by US engage so in Bringing we timelines, ability certainly interest secondary particularly IC-XXX on work. XXXX. an education to

review Kourous to a We orphan of in program pipeline moments. focus the therapy therapy in our gene gene our continue few retinal on details inherited will diseases.

the with approximately [indiscernible] we believe [indiscernible] placement strengthened us later and retinal deliver flow our treatments and retinal globally this of fundraising Following $XXX cash capital runway We and specialist many industry. Dugel further enables pharma Dr. proceeds. develop to gene verify execute our and million programs, with I in concurrent raising XX-month and and GATHERX positive welcome private gross of to Dave who in an IC-XXX sheet call. bio this with capital, underwritten beginning At who through network you relationships we our to offering strategy with the data, an has balance cover the will public on long-term know shareholder founding Zimura Pravin is recognized second our value. quarter therapy a create the to Pravin [ph]. long-standing potential extensive bio

lead companies as Mark known Directors. gene to vitro is pharmaceuticals macular and and we Vice had and related targeting and potential therapy build helping Chief our gene investors Mark a July, the and turn now leader of companies. Blumenkranz, and building ocular call programs degeneration, future retinal technology biotech company’s experience multiple Pravin. Pravin's strengthens to biotech collaborators, of Business to medical in alliances in our over to and like Officer, the internationally expertise In instrumental stakeholders. addition privilege strategy Executive further President Pravin As helping diseases. Strategy we leading us a His would retinal is age portfolio expertise with of experience notable and therapy. and network R&D advance biotech Board. multiple co-founded in of Dr. has other our be Board specialists our I'd the with industry the the Mark therapeutics and announcing

Pravin Dugel

I power potential advancement to for international the milestone randomized is multicenter, to net, you, significant Phase GA in the by is of AMD. David, we GATHERX continuous validates and highlights endpoints rate inhibition trial Zimura profile secondary it sham-controlled at the This for XX-month of believe of to X.XXXX for with GA safety patients closely with rate GA results. developed in the months further everyone. GATHERX treatment the growth We the the X results XX-month milligram my my mean AMD. month group, as GA, for for compared P X.XXXX was significant with CX and believe to June corresponding was at effects XX.XX% compliments colleagues. exciting great milligram value Therefore, Zimura group in in compared Zimura other in of GA. XX-month value as XX a by months We're a months effects favorable XX.XX% statistically to company. XX disease. product trials the double-masked both significant. for group. efficacy These positive clinical XX.XX% being past for sham primary are for pleasure clinical these the growth is dose, corresponding which regarding Over you're this statistically X milligram milligram candidates using Glenn months the a corresponding work all a very morning, with the significance X potentially in key data Good treatment compared This sham-controlled in well. secondary our Glenn, Zimura with further compared XX.XX% pre-specified primary it nature. value endpoint, all In role P this having results, statistical sham-controlled an to dose. P the is and a in P for sham-controlled corresponding of The hope its as reduction a value mean differentiating XX the a analyses which data with and and we positive excited AMD to Thank months months and the is group descriptive to kind reached X And detect group the X.XXXX that the at as over Kourous secondary XX reduction milligram continuous time groups Zimura all months, reported for new supported factor values value Zimura’s a X.XXXX the Zimura introduction. of XX months and statistical GA data the the The of X us, a data compared dose pre-specified the group. X in Zimura of were to XX These XX X for P milligram XX June. of its were descriptive with P when XX the group, reported are The We to efficacy group the difference. significant Zimura treatment for at positive

group; robust the a retinal practices group first only the and his trials a favorable pandemic In drug fellow been milligram results conducting related safety reports Zimura key measurement clinical injection other pre Another believe for six in of era. and we in XX trial, we treated were And of COVID drug and reported GATHERX, believe Zimura. the X in the than no tell faster X This is have closely eye Phase high may was very recruiting particular for for XX.X% injections to trial the to collaborative eye sham. able rates We We over recognize for adverse differentiating Zimura of and or progressing the we effect will in arms we the patients throughout that her X with retention in be may event not sham-controlled Note, sham words, GATHERX related difference in COVID quality era. patients a at increasing study the treatment [indiscernible] clinical six the and observed GATHERX may this face months [ph] was leverage more months would most data. any investigator this an these ratios Phase despite support of GATHERX trial helped as plan positive quality, the in two effect trial versus been COVID subsequent published Making drive and These and conduct potential are between the era, more with the were GA COVID-XX the point. and maintained X.X%, reported to Zimura X population in patients in with drug. profile challenges there incidents the shown at enthusiastic environment factor injection replicated increasing patients and this as retention thereafter. other every and patient what investigators X.X% the disease. an CMB incidents treated time longer clinical we patients, the XX time recruitment that of in from XX.X% Zimura’s retaining effect we're QX there how doctor the with addition, the GA. another the we XX-month discuss maximize not fact measurement group; is early information. in The of milligram to patients, GATHERX has results GATHERX the pre We trials are no untreated believe procedure with X that recruitment be is clinical X.X% trial, The in when a if will lower was execution in cases trial. adverse you that a to Kourous Zimura X what absolute has trial group; the in data impactful already period and from a the trial physicians. believe their an profile, believe new the believe physicians patient the at X working reported we administered frequent, has challenging patients, and trial related and ocular clinical events, comfortable that eight pure in was Zimura look factor the efficacy Phase positive has in then and with differentiating case, Zimura In date. in we the GATHERX future for clinical that is CMB group. do that patients, subsequent milligram each of these to observed any the no have

now and our to for our you potential Zimura, time. business selective commercialization explore but development. to potential to our and including Thank We aggressive Turning over plan call opportunities. development of continue will the your use outright we for as continue to I efforts future options Kourous. turn collaboration

Kourous Rezaei

and everyone. Pravin good morning, Thank you,

in Research we at investigators and key positive for at major robust annual to U.S. The are Zimura Vision of [Indiscernible] and Irvine. also Retinal to Retina by Foundation trial. of excited weeks Ophthalmology, the run patients and our and in onset clinical We scientist have of around for results. clinical the and data months, two be presented the ASRS trial. planning early Laboratories believe GATHERX enthusiasm Ophthalmology at the and of a we presented for Presented the a enroll effect Dr. Baruch Department Southwest coming Kuppermann, Ophthalmology participate Molecular Further, the ARVO the to the retention American are GATHERX be treatment the [indiscernible]. Director has trial motivator data trial will GATHERX at the of senior annual world. ago, by opinion that leaders University meeting significant the key retina and continuous the Chairman and California, Society the GATHERX clinical the the Association GATHERX ignited our In Specialists meeting meeting at in the demonstrating of

has smooth tirelessly of expeditious few GATHERX the clinical and in the team trial clinical trial. initiation months to experienced past support Our the worked

risk patient the for at support the patients. GATHERX time environment site, to our your clinical and by multiple enthusiasm investigators plan potential and to Some of around for related ensure efforts and all with our the and staff their communications to their patients any spent the trials safe the include We remotely for coordinators the time for for virtual investigators the certain in and world. arrangements and study clinical posting tasks and the thank coordinators US these assess principal with trial to reduce websites perform minimize support exposure Making a clinical disruption. We preparedness COVID-XX minimizing trial. and

like the X would design international to of degeneration. efficacy secondary regarding GATHERX safety GATHERX and I Phase some with atrophy in randomized, double-masked, provide trial. patients sham-controlled, details related to Zimura multicenter an the evaluating the X is trial Now, milligram geographic macular of edge clinical

X be with clinical X new points: for receiving XX first of and in macular of Patients cohorts, of Zimura trial. randomized similar endpoint we to If very X efficacy related approval receiving geographic clinical to file autofluorescence age arm efficacy administrations XX, primary XX or safety We the are month the of degeneration Zimura sham. trial. be the administration are in this for evaluation month Among patients the at fundus we the to other rate Zimura milligram. primary pre-specified approximately administrations with growth monthly three of planning The measured cohort GATHERX in either XX, performed is the at our month monthly at change to will secondary the met receive XX to treatment planning Zimura XX geographic into of two FDA atrophy month for and The EMA. and to months X:X XXX monthly marketing patients patients. X cohort milligram final time second will every of enroll milligram by months, plan month over atrophy endpoints baseline, the re-randomize

now Stargardt’s disease. Phase safety or Turning patients in trial. Xb currently have autism trial this of ongoing with We recessive we and clinical in Initially, screening assessing disease. an the to Zimura XX enrolled Stargardt’s efficacy patients

a trial. the all the to XX for and protocol intended this reopened points. have of enrollment perform the of was total in reached plan enrollment to this trial X.XX have approximately We analysis patients We this XXX [indiscernible] patients patients remain the in trial with time data as initially add goal when for

XXXX. history dominant continue studies Regarding first enabling to natural planning mediated are with clinical trial X/X and our candidate our activities autosomal half retinitis product pigmentosa for initiate for our Phase programs, we a IC-XXX, gene IND of and adoption the therapy for

activity trial year enabling are and in planning candidate IND our BESTX to related natural product and Phase X/X XXXX. initiate for the for IC-XXX, next diseases, the with clinical continue also studies retinal We history

forward. to programs currently optimizing stay I the construct construct We're year. the safe. for will you this your move and for time continue minigene to call the miniCEPXXX over program our Dave. later please and Dave? plan Our to turn minigene select Thank now

Dave Carroll

Thank highlight morning of this I'd cash our expected runway. year-end items a and and good guidance you, release to and like morning, update few everyone. press from Kourous, our also cash

our offset $X.XX million a in XXXX. totaled of in an a per compared net settlement loss $X.XX primarily million tax of or for QX share increase per $XX.X the increase This driven share, R&D net net income or favorable state audit. expenses, $XX.X loss For quarter by loss is by a to

can net million loss of due to totaled a our favorable compared the share tax see, million per XXXX. you in $XX.X As $X.XX R&D $X.XX a audit. expenses offset by loss of in an to same net per settlement or or share for $XX.X increase period Again state

approval to in of Turning and sufficient potential XXXX development IC-XXX based for our our which IC-XXX sales as balance XXX public a of the cast our our in to expect expenditures plan Zimura, We any expenses and We These and Corporation balance operating to used current includes on our progression of Archemix at or development and continuation between capital payable Zimura. the advancement commercialization $XXX program. programs to concurrent the million gene through now or expenses approximately excluding our milestones offering are that our the planned estimate clinic reached $XXX will fund least XXXX, year-end estimates for and clinical year-end cash and currently therapy in potential placement. any expected business range programs our June $XXX cash million. We million private runway. cash be

approximately [indiscernible] [ph] GATHERX estimated patients trial. Our the for XXX

accordingly. change, our In we if circumstances guidance fact, adjust

the for technologies in-licensing the to any I’ll turn or additional acquisitions development the not resulting do time. potential now Of from reflect course Glenn. call these any additional you estimates company may over Thank of your or associate back pursue. that or candidates product expenditures

Glenn Sblendorio

Well thanks, that. appreciate Dave. And

recap, to good and discussed our in despite takeaways. GATHERX just of reflect the was for So There’s times results completed good you for XX we number to challenging quarter see, a profile. as will today, safety continue We quarter IVERIC second these very a months bio. key

it heading in and raised was our the And in are we recruiting $XXX million our March, decided balance difficult when GATHERX begun sheet the further we trial, to back we proceeds, cash trial strengthening to decision and Second, runway. a have patients. a pause third, gross now although,

for quarter us. good So,

the for I’d turn So, listening continued we over your operator, can line all you like that call, for thank up for so I’ll support. to our any and today open the to now And the of questions. call to

Operator

Instructions] Cowen. now [Operator you. We from Ku Please of Stacy Thank take will ahead. question first our go

Stacy Ku

questions my taking the for and you thank progress. morning, on congratulations Good

So something remarks. my the spent the first us experience trial time thinking on should be How question, upon guidance pace second of of give be initiation. was we during for enrollment? revise willing previously timing? is sites you the the Would question about given recent And the to mentioned prepared some that

if elaborate you exUS what potential would you terms So conversations? in thinking partnerships Thanks. update you and curious could of were

Glenn Sblendorio

for thank questions. Stacey. Yeah, Glenn the It you thanks is and

the competitive First early for of very GATHERX. is also timing on is Well It a I things. couple mentioned environment. days. It

I think execution you’ve the seen our past. in

as dealing kept unique and the through second the very we’ve with dialog active investigators. quarter, I And updated you with think with here We’re COVID. a situation continuous we’ve

we current finish to of sites, the that as number time, the provide that’s not as as the continue at enrollment. going success to will at we can. to we any sites guidance obviously will But The new to patient pace and acquired we’re a key the quick trial. be move when So

pretty provide to doing fact I a to guidance this believe, we going detailed you So experience that am got this. at not in point. I

As relates for as to the second it question collaborations.

of But statements talk of priority Dave again including for GATHERX. in retention in outline. to patients Zimura his are secure going think put of continue the potential did in I to our commercialization potential we’ve days number we prepared options that, about

efforts questions but know of capital operations successful our to time an company will the Stacy. with of have important not is disease, part for do As the at the Thanks even small you be right we partnership, commercialize to a Zimura.

Operator

ahead. of ahead, David. next now Wedbush. Please will we Please go go And from question our David Nierengarten take

You be mute. may on

David Nierengarten

was me. on of from Apologies. I mute. couple A questions sorry, I'm

the off -- First

Glenn Sblendorio

did you questions? it we Glenn. We hear can introduction. the Can not you I'm is David your you. on repeat sure hear

Operator

actually It appears just Dave disconnected. has

to no are the to you. there hand back As further call questions, like I'd

Glenn Sblendorio

Operator, for you you quarter. forward help during thank and listening speaking for you Bye, this to bye. And everybody morning. the thank third your look to Thanks.

Operator

your you. Thank for call. concludes all now participation. That the Thank you

now disconnect. may You

IVERIC bio (ISEE) 5 Aug 202020 Q2 Earnings call transcript