Adverum Biotechnologies (ADVM) 11 Aug 202020 Q2 Earnings call transcript

Thank you for standing by. This is the conference operator. Welcome to the Adverum Biotechnologies Conference Call.

As a reminder, all participants are in a listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. Instructions]. [Operator like Relations conference and now Lacy to turn Investor of Corporate to would over the Myesha I Communications. Please go ahead.

Thank website we update. of at the available issued quarter of new welcome, A our a financial section everyone. copy our corporate section on of presentation website. release portion Releases ADVM-XXX, and of reply on the trial the and Presentation the page OPTIC share copy available second the Events the for clinical slide and Please our data Relations you, to Investor www.adverum.com. of Press is of from today's provide will report call that this X of be XXXX release results IR of and a operator, note press our Phase Today, today's a business of

Fischer, Joining Thomas Officer; Executive Chief Officer; me Leone Chief Medical Leung, Dr. Financial is President; Chief and Aaron today Osborne, Laurent Dr. Patterson, Officer.

honored new Arshad INFINITY the University Dr. Eye and to He Professor at Associates, principal Ophthalmology In Sierra addition, top of our in have Clinical of Director in we investigator also Khanani, will and presentation, the will of of After Research Dr. data. enrolling a for investigator present principal is Khanani questions. his And OPTIC. the are we Associate Clinical OPTIC Director up Managing Nevada, trial. open

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Before we to is diabetic finish, ADVM-XXX in edema. macular I trial Phase want a you present INFINITY to of INFINITY. X

in edema to is time, this our a who working long and diabetic in clinic On basis, country. cause reverse for diabetes patients one adults As we had have a who of blindness you for their in hope retinopathy know, looking blind see number the daily vision. walk macular diabetic

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kid, pass looks blind the vascular see to So retinal these I'm to go I'm their brothers, patients. excited friend, future for diseases. don't going sisters, Dr. bright that Fischer. And really to now with

gratitude discussion video. Thank begin Dr. before patient, to call, I you, would introducing of the to Dr. caregiver highlighted the my like this for this Adverum Khanani. Khanani we express portion in And

vision from wet in to patient I on one and patient a on phone for to the and ADVM-XXX centric for those time from it to the question. potential hearing for preserve approach is patients to like such as burden the call operator order now think why a could reminder the in the to I'd directly emotional questions making more firsthand vision them with the as over DME. treatment the open the offer first turn testimony stark AMD treatment

Thank you.

question Piper comes ahead. with Buren from first Our Van Sandler. Please go Tyler

and it's months. Good afternoon at continued durability great see the XX to

one I on of and questions, interesting. are You efficacy earnings on guys certainly a couple safety. one have keeping

and early go more at But of they that is as The I on Cohorts period anatomy. Cohort you looks and anatomy current like and -- improvement out does imagine it the X maintain a whether that it's to longer too visual pointed goal X out efficacy. X and X you to first seeing in X look clearly X. you're as to time, versus the appear CRT But say the one acuity and release. Cohort in

second versus to get encouraging want So safety, And about I safety from early you your mentioned you thoughts inflammation. on ask and X fewer that. AEs on -- question I inflammation. then the to on posterior less wanted Cohorts specifically X But X, and

that are You similar or said you events any. Beovu? observed haven't What seen none been has abicipar what the gives you to inflammation of with confidence

out Thank patients burden, had they're really here, of whereas that patients at goal so Adverum. improvements. much. vision maintaining you, whilst the have their I'll Cohort baseline. have improved of And cohorts, these CMO so treatment actually pointed reduce injections Tyler. we -- wet take in do X to having at to that for been Thank chronic is difficult that that anatomy largely to AMD, the the anatomy. -- many one. That's manage. you And maintaining Osborne patients for who the but some -- some the the these is see And these Aaron seen been you the goal that happened fluid and injection patients what’s essentially essentially across we some there's for

resolved, getting You Khanani is then have often patient was can because to the saw focus patients, vision thickness with to Dr. with the improvements that fluid improved. a see baseline and not effects able it's improvements anatomical It's a been on actually than pick for But some well, by more that vision. there improved best small experienced see visual patient improvements, it's fluid. had delivery nine surprising of a them that presented, Cohort an and anatomy has as with ADVM-XXX, frequent injections that lot get anatomy anatomy to on there is who as But we the X, and eye central study case. retinal still the well. be in you continuous you of the earlier that when

clinical think, to terms trials, information have direction has there is to as managed, not of steroids clinical covered. stronger the were that their with -- really the Cohort examination, the to back look he all many how where obviously string minimal been these that now across needed steroids. and the of of and in seeing is early after the we steroids. efficacy points or with With wanted We important eye? looking you Khanani topical also steroids I well. of data eye data. control well, second weeks it potential oral of topical trials putting and delivery. to at which mean, including obviously zero posterior we're overall, inflammation, And period I'd been these in down steroids here been think safety. within order X, But share these some I I those previously X on the first it So early this because XXX, the And bevacizumab abicipar really regards continuous X, to to none full in in because particularly giving from more that can Khanani? bring back and Dr. investigator the do manage has that to regard fact for giving we're to receiving we're in question, when like of was steroid time topical is share And information a is form it's as Dr. that what question, during inflammation. controlled drops perspective. And is perhaps has the an than patients We just Cohorts sure that have early, carefully

thanks, Yes, Aaron.

there's itself, current don't have wrong. comfortable to the we to to anything we look And the of the excellent it think X for patients And me inflammation with vasculitis. question, panniculitis white. and abicipar back, tell and you in saw patients you eye coming and safety let you don't are And study, intravitreal full was make blindness. vessels frequent, two you, cases you especially for market, injection sites agent. CEDAR with are tell with I need you that will which need We that, and something sure in you of that the presents I have for the call had XX like I that's patients an study, that's because, bevacizumab, profile were an abicipar top that that's get irreversible Phase or

seen I discussion in there vasculitis has been retinal some HARRIER. occlusions about that artery and So, know or subclinical HAWK were

safety. Obviously, I not of And molecule, XXX on XXXX new cells really including think of the the think for we and fact they're the at the in it's vitreous mild I eye, is since with not from if confidence seen a terms I the are lamp you aflibercept is the some in anybody is have vector that look cells, It by and inflammation, we the front data have slit which in front me have those is inflammation. spillover looked of eyes. posterior aflibercept.

first tell to most So large a understand that quickly ranibizumab not fact I need you XX the topical having we front, is anything want we now I'll what with OPTIC number, abicipar, FDA let’s in to patients. the that's Why to people for of using is, Tyler injection attention have resolves or And say would really exists compared with steroids. the I concerning the are didn't people have line physician incremental bevacizumab, thing really Beovu last or pay had intravitreal in or benefits value and seen did is this abicipar to patients again approve seen because information aflibercept. not this of they why

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long getting changing -- vision the and of terms you're anatomy, controlling the in vision and disease. stable the disease, changing of you're You're you're course essentially the term

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next question Cantor from Fitzgerald. Our Instructions] Young with [Operator comes Alethia

the one. Though of of I've will I a kind gotten patients around steroids. lot guess, ask topical go of one many, what to cases questions when try I their off I is have that of happens

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can And perspective. over who from additional So some in I have what source think, OPTIC. Dr. we to Khanani I'll perhaps his see hand that's clinical

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will not a it's four need forever. patient day like So times every

them two that you are look few are small. number if times who on patients, But of the a off the is a There of day. Patients drops. actually been or need on have majority majority really, So four. at every drops, one cohort

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we over don't need and them need do, time. majority it of make to who that's and drugs slowly to learning, ones So taper take sure a just the

Dr. Thank much, you so Khanani.

we think question. I the go next can to

with next Nadeau Please from ahead. Co. question comes Our Cowen go and Phil

to made, question. up my I Dr. comments as the on follow wanted just Khanani you

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expand is can interior what us just sense, you inflammation said, too So your much. as to on give much you maybe how

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the point video Majority patient you and the me looking I on at one and of done. of saw this know, And think longer. know in, that a XXX% end I but that's on for saying, talk don't the treatment all have think burden to a patients that at may daily about agree you're be which that because but the you it's as need it? about. the required were six just I you they’ve day, said may patients weeks group drops of do I are see you we will And going willing at basis

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in And So benefit we trial where to know, only And are I the would not this would enroll as before. at my think any physicians, a as key. those said I before, I've mother, said treatment. it I I of want look mother, you participate mother-in-law,

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game I showing there is trials, patients with had So manage a a really, how trials I promise, roller we AMD. in think, lot studies terms trials, think, I the I where many in most but I am I have of think talking different changer are patient, this all of vascular

go And Dr. question. to so next we Khanani. you the Thank much,

Please comes Sachs. with question go ahead. from Our Goldman next Suvannavejh Graig

that [Technical how that then, your pivotal in in inform dosing to if up look Difficulty] prior patient's like patient in maybe and eventual what trial maybe until progression Cohort X retreatment AMD?

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trial? the want response the seen doses informed was question doses, pivotal the we've with the take to you think I in between two forward

who Yes. patient new And treatments? specifically one required the

changes look the visible. small them very stable see at they they to criteria burden language trial there's Thank prior. are we're And the rescue the to demonstrate of moving in X of design evolution Because did of disease rather having the finding big terms definitely using these, injection received had category actually blood a had rescue both in at benefit criteria. the Roche we click or than just stable, was update decrease why the these these But they you And question, We’ve in single think of a patients in patients a clearly data edge retreatment really these Greg. pivotal injection those in they and single in of seen for retreatment appear terms than I anti-VEGF. may from really, were positive the delivery only When fluid we when most criteria because that just patients relaxed system vision. criteria, both these the were is that they we a the look of injection, see the the and this amount the need more delivery the the and in retreatment as response disease port of of Phase of sort both meet both representing a When of appearance from also, supplemental changes new our patients retreatment both they with continuous injection Genentech OPTIC. more much ADVM-XXX patients They of potentially using another like where additional have of we only injection. rescued program forward. represent think this because to we

to that of So, have really to may small need amount more fluids be not. despite was was before shows the And look injections they at a that I we benefits at patients in whether potential think delivery, continuous as present the allowed shows retreated of really that or also was of but ranibizumab. who same need there vision of study, these and there saw maintenance retreatment fluid performed. be monthly level We

Roche these And again, seen So we across I to terms there. into may looking potentially the analogue to cohorts, I reduction. back hard respond major disease to dose we've well. disease to who We program that patients, think port We've earlier a move reduction at as forward there’s of treat frequency move an had as in patients low delivery benefits seen later system we've mean, with in even can very the both better the injection in slightly OPTIC.

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Our next ahead. with from Securities. question Truist comes Lee Joon Please go

you be that wet would monthly and in IVR, with or safety two-monthly if trial potential on design non-ADVM-XXX be the injection? but typical clinical get me mark AMD wrong, the steroids about the two-every Correct the will par ADVM-XXX injected for conversely trial? the Tell just I'm care. and likely the Do us of also efficacy best prophylaxis and non-IVR standard the a get of feel

you the Thank for question.

program. that so we delivery turn analog port pivotal I trials, program Roche towards trial discuss potential And mean, pivotal system, as as the is a we

kind that followed they showing Phase that did use very a by And program, with trial that this the to two So look is we reason analog of at Xb doses have be risk an stage that positive early ratio. benefit trial. we as sequential pivotal

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we a we take we is to we a dose to doses. we So forward, single as have really AMD what -- do for single the At have moment single would and would dose, tend wet to to to a market through two need a move really that trial. we we Phase dose intend get X

performing to larger of seems at a step. a both doses look So those next study logical very

initial is So that And be given following doses. in our month, the trials aflibercept compare three which would aflibercept. registrational to intention every monthly is typically really standard-of-care other

you we to essentially, acuity you from population the of that our point, visual if we for every whether that questions be We're XX% looking X antibodies. at patients counts. And point, and sort OPTIC. are have have mean testing of them these aflibercept you one data the some At doesn't There that open both will a preliminary nine moment, the We but need injections. screen a patients we profile. a take of experienced, we're would that as through treatment primary we maintenance we've Phase comparing positive at as But few go high around looked well. would out, take final both forward show with study in And have neutralizing we've is months, is all. in region the patients. that neutralizing patients here would relatively So can think of other to endpoint to screen that towards we antibody trial around similar then questions in early we month. disease, with head doses And got very the need to select commercialization dose. aflibercept of to currently are From open other

question to best patients the forward. test adapt and include go that really early trial on, trial potentially comers in is as where you screen we small the can a So relatively we can all

antibodies, feel our neutralizing a to questions two with dose, with around So we Xb trial do Phase doses.

as Looking in regulatory part at and is intention of the of program planning next we're doing the looking year. meetings with lot now the discussing trial pivotal that starting these authorities, with questions international what we're those makes program. FDA of sense And of a mid forward to

comes go Leerink. Foroohar Our from SVB ahead. next with question Mani Please

uveitis timing which where around data, Cohort of of already begun which a be second then in mid to a experienced in EU in uveitis into regulators meeting about begin those design And complete pivotal any there the part X end is for you of regulators. year. for previously recurrent release Is patient, a at you of will -- apart those sounds interpretation kind It next answer, of communication with you to or that U.S., of will the the that So time more of question, horizon patient, in this cohorts having are study of conversations? the the think right the disclosures trial? conversations Or is of prior we have as when where the are patient trial, out one, the that within along guys you of are and press with other recurrent the work Phase year, of from plan correct? data terms in that the X,

the because that's the so recurrent a same uveitis X. easiest adverse within XX, Mani, take it’s uveitis patient from event patient trial. second here. patient of I'll the one. second at week that it’s it's but question, had the that Thanks, occurrence Aaron Cohort No, an the history first, And of have in did not

recurrence trial. with tapering topical was steroids the alone, that and at down improved to chamber event the being I they And first now in the anterior as said are that zero. to So them has drops cells

With X. path, discussions regards the number with in obviously that's ongoing we to in are two regulatory patient So FDA. Cohort

phase end having ahead INFINITY those of with start together number We including a have requirements, a we masking those really of FDA and the encouraging started way not mid had And discussing clinical trials support of we the clear trial early to And I data we as idea look that to both that, go we've data to have pivotal next discussions. we the program. to of which We discussions put think trial. be trial. have program conduct able got we'll those the them formally and year. discussed want recently best around And package have interactions really of run. really will shortly pretty the But type with to that in a enough to we clinical a And said, on here.

Luca RBC Our Capital. Please next go ahead. Issi question with comes from

the Once issue no hold longer dose that clinical XEXX, versus the regulatory, And that? manufacturing data. substantially here? actually That's you. the you're When question. one. characteristics, cohorts. other are look Thank the on Cohort injections or quick of it clarify, Two what is the just prior pursuing, the clinical hold And any on to there high lower at the anti-VEGF of of number the months baseline is update related any in why that in possible is second just implications the again, XX both? two, difference? the potentially patients partial was the And partial to I One, first was X in

It's here. sense. makes and that happy regarding take second one to part, if over hand maybe I'm the Leone second to Aaron the

seems the Cohort so presented. that why in a really -- are Khanani it's earlier a X, on number Dr. number disease point. in There are regarding months. their you And Cohort of lower there's anti-VEGFs XX to for Thank patients be really who driving So, Luca good some the question X. previous in

have months coming to as We before been the have some three diagnosed trial. patients as into recently that two

I So they should remind in four our requirement to that two had injections you prior protocol is the months in. that coming

earlier again on we a little And, to that annualized represents an think continuous we'd Khanani increase did are what in in saying basis, increased these investigators from anatomy who that some So patients bit have but confidence patients. control delivery delivering VEGF disease. upwards, expect improve the of was to X.X that is product can there’s in treat tough what terms Dr. I and

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patients some of in have to the those trial. great it's So

efficacy the neighbor, And had my in maintenance And patients great said, improving has terms terms presented you know, I that that have Why now in efficacy and fluid we because today OPTIC. her as we early now, is that's putting enrolled for And data right? longer last aflibercept. year have just it's up, I longer an or worsening I update, think, Yes, are in shown with we use especially that now, one patients. and said, ongoing that people I an so me question, sign we year of interesting of trial of have BCVA patients anatomy. I and course, especially anatomy, one she close and of and monthly

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you. to back So

right. All Hi.

yes, partial of three XEXX, the currently saying, will to hold dose dose have that we that hold. forward clinical Aaron the are the was XEXX And at and which We happened, a and time have this these And don't a was take doses when trial. level pivotal related So was you're our question change we correct day, partial XEXX. there’s at to we study. you dose the escalation probably as into of had that the that -- original part around clinical of

relates hold clinical important. it is the As to why

we these order to to CMC do clinical larger So with partial and the because the believe issues we that related FDA raised And and focus mentioned those a to were company I and CMC, have this is need think that a studies. of removed been it's issues address that hold start our we've I've on and in the we these on calls, to been previous are the priority certainly track. on working

our So program we're confident start they'll be resolved ahead in and we XXXX. would those pivotal of be would removed before

from with comes Our next Leone Dane Please Raymond question James. go ahead.

patients thing when really in are Khanani, and guess of So Indisputable rescue has Cohort anatomical peers. thinking lot guess, injections. had one that, we maybe, your a I I good of Dr. some us outcomes X need speak to about

still Patient and to that, four needed care? Cohort up end for supplemental X, X it's patient How on regular the a how just still that and advocate When guess a standard that certain that have here, also on But situation your they think into explain Cohort you how potential patients? Cohorts having injections still think a be in like follow And out daily up. you as is is for speculation. in degree about of to is in drops where taking but risk that conversation? could you on devil’s therapy, the drops is TBD they're do patients you X non-absolute also do this steroids there’s would Some a play risk, with treatment X of about a a shots after I the of and therapy, to example, and studies there that would X. need getting you you then how go larger with think framed with conversation into a peers for on

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and I one think patients patient disease a is we each can put box. AMD is in different. very heterogeneous

patients monthly We have on that aflibercept have fluid.

bevacizumab on patients every three that have also just did fine. we months While

before, benefited like I where case. this I my monthly have here the treatment value is having for So the have me even saw from conversation aflibercept think seen patients in you

with high having aflibercept, of So was injection patients. a my really favorable delivery levels to single after continuous

So why that's enrolled I them.

treatment? would treatment the didn't required have you would supplemental before have can at question OPTIC that patient So, look are continuous if have study. they into required think they they ask I injections? swimlane the to if you this patient and the more what this were Could delivery monthly is, plot, actually getting got see on frequent

So AMD free. patient will Nobody the heterogeneous is is be beneficial injections. that saying as disease injection to I less in think for a XXX% patients it's of still get

patients that majority acceptable get end of reduce acuity, goal can and my I with not if some with burden. peers. is, we have of I if my the think, very is controlled, to supplemental me think our need even maintain disease active visual But I for to continuous that's the At very patients and delivery. that's control question. think answer day, and the treatment, very the free think there And more are injection would a didn't they the I patient good been disease frequent have injection treatment be

Our with Capital. next from Please LifeSci Dolezal question comes Patrick ahead. go

in sort into negates satisfaction product worked the standardization And kind steroids? any at In injection avoiding the monitoring Khanani, profile there spoken to do following regards reinitiate greater particularly visits regular a XXX, process And patient you've think of avoiding emphasis of what required itself? Do to or on you protocol Dr. and the some administration envision lot you the about follow is a to-date? of injections patient of that of, there treatment. first being in number starting OPTIC is benefit those visits of up given the of earlier

just a first the I'll for part, take there one the great. second. question and try Actually, reminder Okay, then.

In was follow-up on how they and change that And forwards delivery schedule, anything the see steroid their change on So important are can Dr. if we from continuous and a I studies, we'll Khanani, over and differences. them say really world we're that. assessments. it comparative do XXX to in would as we to the need to do sponsor treatment. moving continue in you patients think I'll perspective, some following extremely patients and for getting I to the need the OPTIC real obviously, because to move closely, I of to hand there's think question specifically And the see need study, we up

COVID-XX. come scenarios to up extend with plan XXX around We are we follow a situations patients studies, have extension particularly to which study We've many OPTIC patients that that couple feel these visits already with a seen who benefits opportunities of to full. the And for in in would have follow with due that actually some can visits have to example, skipped years. potentially concerns for the patients, we of of potentially these the

of potentially HOMO change monitoring, in with points. than experiencing and So mean steroid could looking that example, regimen question disease. I need CP are they need with as for to Patrick, checked such we patients to that technologies at that time stability ADVM-XXX come be we're show carefully, really around a continued and think they I

period Really check. lot And a of need pressure a However, they've front of eyes is been easier the on then just the eye check, a to time. steroid for drops retina they often intraocular than specialist. which going

period put diseases, to schedules whether see a you visits, ADVM-XXX, intensive going regimen. So need to together of in towards relatively commercialization, follow think need I rescue monitoring whether our least their terms with up at we to steroid patient adjust when following of monitoring needs going CPP you're a and monthly

world? I we're laser-focused and got and of real so benefits essence the monitoring summing think Khanani, maintain think the forward I that. patients of I the I this. where for can up That's that you've see we're timeout the of the the delivery. mean, schedule real why how now. visits, position But, working most on really CPP outcomes. achieve. what the without out in it's you where you because in improve dramatically And we're Dr. you you question can world goes in trying continuous thank as kind vision do to and OPTIC intervals, really that's And realize those you why quickly, very on that’s extend that's frequent

been have delivery sustained I've is Aaron think involved in I lucky trials. -- that four this I been

So, we one Phase X, the port study, study. DME extension and Portal in also the top X are system enrollers of Phase the delivery the

of and We the are RGX-XXX enroller for obviously are part top we ADVM-XXX. then REGENX

member. were clinic to is and by questions asked. in itself better two OPTIC me Patients than first an system just their bug one with quick clinic test. plus or daughter can issues. that are visits on on sure come a smile whether And having in they there face. make off for visit injection? their was, Number So any have their in a can good just and moving they few what they injection. keep a after with smile, the think getting go like I themselves, And They initially, happened taper the agree it's make RGX-XXX come they're they sure know they you, because monitor response they to family can PDS, drops with cannot They that's a have of an any time then that need happy, months. delivery that not they and majority you life patients, And with without other to XXX, their the I sustained drive delivery and are

two patient no So of does six controlled. like or see at two three it I six probably to had in let's say weeks think months, that patients, they're drops a we months and I two patient them. is three if their or that inflammation, would disease after. have we'd sometime we see months our months And don't maybe doing they to don't well, like see every if fully

patients twice If they anything world dropped, first year know that macular going not a I they're so, in a a have even which or go on they after every steroid stable. edema That's came of and injection caretaker so or I visit, Once coming that on XXX maybe patient for family is cataract too. to So the from two or real somebody have then lot to post in longer improvement I or I that. drops compared monthly can see month a visit, think plus in IOP other like surgery huge wasn't burden. the they're months spike, usually uveitis

they to three a day, if even So for drops patient to needs that has before go inflammation two that follow twice up. to a can a mild easily coming take months

XX% can be events. huge also it's answer XXX%, will cut by you visits, if or less win. a injection which the will or the So clinic that down burden clearly into is, And XX% then translate

is clinicians edema. think, as the like this anti-VEGF AMD to macular delivery I continuous eye that in I very blinding and neovascular control patients and promising of diabetic think So diseases really

for to remarks. the I Laurent any conference concludes This would closing session. Dr. the like turn question-and-answer to Fischer over back

truly like patients Thank perspectives today during thank provide participation make and for thank continue a this excel they last care not continues but the to clinical trials least, Dr. even data as And to to on to very acknowledge and wet This joining for possible. the we've and Khanani to insights learned sharing to productive to AMD DME OPTIC. we the deliver critical suffering assets our and with thank deliver us on I us from this I questions. joining quickly his patients for pandemic. team the just as the the today. millions I'd our our everyone, been globally. the employees, team, to professionals that right I'd right patients believe discussion the right and their frontline for has ADVM-XXX have like want strategy again to ADVM-XXX in during pandemic from great to available mission their of you, healthcare

our upcoming end, we reiterate Before quickly milestones. plan I'd

be of data from we'll year. cohorts OPTIC four additional presenting of the end this all First by

and and be report will ongoing trial the to half data everyone the XXXX. the our into future. mid-XXXX. Take planned a much. continue in in of DME, and ADVM-XXX progress Please I INFINITY continued stay care. trial well our to INFINITY X to pivotal Thank updating look Next advancing forward from on very plan healthy we And finally, for we'll second Phase in patients randomize you

This concludes conference call. today's

You your have a for Thank may pleasant disconnect lines. you day. and participating