ADVM - Earnings call transcript Q4 2020 | Adverum Biotechnologies, Inc.

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Operator

Good afternoon and welcome to the Adverum Biotechnologies Conference Call. At this time all participants are in a listen-only mode later we will conduct question-and-answer session after the prepared remarks as a reminder this conference call is being recorded. I would now like to hand the call over to Myesha Lacy, Vice President of Investor Relations and Corporate Communications of Adverum. Please go ahead.

Myesha Lacy

Thank you, Anastasia, and welcome, everyone. and press our share or wet program business a for development wet issued XXXX recent for quarter ADVM-XXX, age-related progress we release our to planning AMD financial Today, results. fourth our macular degeneration on this the page section our available Relations www.adverum.com. Press corporate Releases A copy website is the of of announcement of Investor of note the Events on that be also available the Please Presentation reply our section will of today's call website. and

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

Khanani, addition, the enroller honored In INFINITY today. are to we OPTIC our Eye have clinical an Dr. and Arshad joined us of Institute, trial and Sierra in

activities, we forward-looking operations. our be As and those caption our which found to to a These these the subsequent statements filings Form September making be the description are any from Fischer. materially can call will fully will and results Risk now and now forecasted. cause reminder, actual upcoming A may anticipated of uncertainties subject differ that milestones quarterly quarter plans, XXXX And statements, research risks the include Laurent product development to XX, turn our under SEC factors. for more the heading over XX-Q under with report CEO, I ended on Dr. Factors described risk the risks in

Laurent Fischer

thank And and today. us joining afternoon, I everyone for Good staying are friends family you safe including that Myesha. your everyone. and Thanks, hope healthy.

product in and differentiated in DME. options as like clinical known participating have outcomes. with dedicated patient well for Khanani all our He's field and world we'll [indiscernible] about with treatment time, joining team a today. during to I also patients appreciative we're treatment mission their pandemic potential At us and as and patients; we we know that gene as are impacting option disrupting retina wet wet to incredibly this establish trials. gene of and to of and AMD talking investigator pioneers patients, in for new enroll one-time thank patients our Adverum, an to a population our global the studies we're we life. for Khanani technology, expertise that deep which continuing many to for We're is as begin, risk would personally therapy a be potential vector Before sights I real thank Dr. at ADVM-XXX this new therapy therapy novel families would Arshad advancing AAV.XmX. of his anti-VEGF the therapy market this improve like at is that AMD to the his believe who today. forefront the preserves We're investigators to Dr. experienced very the

living alter dramatically as wet and keen DME to potential it the AMD for and paradigm as has efficiently to technology intravitreal patient injection a following and Our available with we're treatment patient possible. the as to single soon make in-office

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We will share about more in the future. this

and in over challenges during have in Durham, six to that soon. company approved we call Aaron. to and would I turn the Before we now we the to to commercial pandemic, a acknowledge COVID-XX. to to to the as the now our optimistic Carolina. than want GMP in vaccines hope take We're study new return Aaron. over INFINITY complete call precautions Aaron? manufacturing to invest impact to to continue like facility were in I to of enrollment normal North I turn Despite less navigate this three a months able

Aaron Osborne

that it ophthalmologist fortunate to with involved how essential I've XXXX Throughout many my anti-VEGF achieved our with career, advance wet perform be activities. important progress AMD. is has be to of submission. always skip sense. BLA we've the planning easy believed an ADVM-XXX daily our is in is that to being been towards and it a significant our lives the We're been I've to good vision I trials day-to-day initiating development most of just and is believe programs treating Phase As X excited key field unless vision In threatened, the

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XX% have injections The those slide ritual annualized free the ADVM-XXX also dose the ADVM-XXX. before at of entirely At anti-VEGF following swimlane has a afterwards we see from doses of XEXX anti-VEGF whilst can you frequency; with observed have on an patients in the of we weeks substantial both ADVM-XXX plot, frequency injection with XEXX following the remained whilst reduction. As at these patients doses. in frequent median both There reduction been follow-up. saw majority XX into reduction injections XX% a of injection

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or every XEXX based trials, these receive approximately eight corrected aflibercept not In or to change aflibercept patients prophylactic will from XXX and and to on single we AAV. or will IVT injection OPTIC, baseline a non-inferiority baseline phakic in on receive serum best of regimen. randomized year. exclude patients will patients eye ADVM-XXX a visual pseudophakic primary endpoint patients include XEXX will to months will The Specifically, two steroid receiving we to weeks. Similar one neutralizing in antibodies be ADVM-XXX both drops out acuity be based

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transformative investigator to of rapidly enroll in-office look We tremendous have We given investigational with to therapy. OPTIC these working the in potential had studies. in trial INFINITY and gene our interest sites forward

Khanani, well. progressing study patients want patients data enrollment Before data longer primary present be I second of followed study will three-year of extension one-year turn from study in data the future In macular for plan X. completing of total is this further earlier diabetic from this at these plans OPTIC ADVM-XXX. year are data the outcomes OPTIC, present so Dr. now include enrolled The our a complete importantly into control these focusing to We term quarter share the half year. second INFINITY After edema Cohort we study to two-year patient I from five this years. this a being medical year to randomized on endpoint in in to also call over and plan a conference will who the

advancing retinopathy. who in the We patients very have IVT are gene therapy by are with injection pleased progress made we our AMD wet living and for single diabetic

Khanani in now about one is is clearly for center I We we a his patients why transformative turn for this the video treatment patients over will this sharing wet to Laurent. that providing remained anti-VEGF of their have the After patient see which option sharing are as with others of and of development. the additional of living call is what trial. experience potentially of the perspective. platform disclaimer living potential Patients a we ADVM-XXX Whilst remind This have we advancing counsel extrapolate and video to Dr. they well want future at with before results fireside programs supplemental we to opportunities a testimonial. that clinical don't chat the inspiring majority we're video, believe include not legal is the therapies video participated after the AMD an But video, are need In patients everything provides to as this patients OPTIC do millions wet we bring this our for injection hope the Adverum before obviously a the as esteemed journey with I insist we in the and you AMD. to that we developing, OPTIC that patient have single patients free, and therapy. our these into picture. share

the video. [Audio/Video Let's play Presentation]

Laurent Fischer

very thank incredibly all and rely with you're your disease. their experience your for Dr. It's the that patients' on of welcome they manage you with to as patients sharing Khanani, me us. to expertise connected First clear

share like I that slides these you would how around have share us few a your think responded slides few please? showing us to with ADVM-XXX, comments a you patient you'd to

Arshad Khanani

doing, me doing. this video I so breath Really deep every having to motivating. time so for it it here. why to because this I is thanks we're take and listen what and at Laurent powerful Thanks look have we're and is

treatment to lives injections having are the lives basis. of of frequent who here their activities the struggling we nature uncontrolled disease and are opportunity with continue with burden, this We disease, and daily with see on a the daily patients that live basis them a an even their transform to then on

So I'm I therapy move going I obviously trial of and If to it. do excited here. this this to be slides of part prospect the have the can forward.

is for So the patient. this slide this

visual retina you her even patients is and persistent cystic left have patient those with disease see the on the video. vision scaring on had changes and in required period. There's weeks a supplemental can that's and aflibercept as saw discussed after just as early during we I you was dose controlled saw ADVM-XXX where my This her you for no was OPTIC no time some not can activity. and weeks can of who now. activity low prior see experience, is know, the an fluid you physicians see her disease of her you OCT this know, letters black after XX you does she there the that injection like So disease I you a injection underneath offered to she has she see see trial, why positive on frequent based the can in-office XEXX, a injections and not single perfect. because few and basis, as monthly baseline But ago, acuity see her looks you single how treat we not can injection can OCT XX

about and data physicians this why see That's why that's it. are my patients are why drug colleagues, see that's this that So of power are excited excited. and the excited

this things. with have was of think to meeting. patient seen weeks of Number many aflibercept four case highlights is go of mine. this one, to patient it Angiogenesis Let's us injections. the And Most the before, five I have latest in not this two controlled case meetings including another this slide. next presented at we But

patients HARRIER who acuity. know poorly is at is data wet can So their now those retina you and the and fluctuations we of getting studies, long-term bottom fluctuations and do where and wet in as dry [indiscernible] the can see actually in CST disease that controlled and terms trial HAWK on and dry the there is see not as based well the you have CST visual fluctuations and from

frequency and because lose have levels treatment we're can I injections single transformative patients who from essentially disease as I this injection we being can we this control when not single having and vision will modify at and their look patients the majority but I steady also at look anti-VEGF in-office disease injection. because with such So can that regular of at look only long-term a control aflibercept treatment, of in-office for getting a

really OCTs really, you So persistent in-office has fluid single see injection after the patient a left can done well. on the has in patient and

and has continues dry BCVA significantly at XX after the can weeks the see You letters be increased or OCT to eight XX to the treatment.

my a is Happy share I'm you hear you to the moving thrilled any pace. So here with have. that to take very the my really goal excitement programs to and excitement Laurent, are today patients and questions at rapid forward

Laurent Fischer

Great, so on Dr. thank that color this much really and patient. appreciate Khanani, you

the in patient the you of bilateral what shown would the eye her Your to patient treated other develop eye, has XXX? injecting be second with consider potential AMD time and at wet percentage

Arshad Khanani

Absolutely the The has Laurent. with we've injection are a been The potent. single efficacy patients ADVM-XXX asking. in trial seen so

patient this year. that of this we is the XX% not disease But know obviously per does risk at point. bilateral So

get the current one-year saw for just in those I coincidence, injections said, get it's trials like fellow her, my asking treatment she's giving I been So eventually fellow obviously is you're of treatment one and have eye. But clinical And problem fellow when patients in asked treatment it. in finished the the the fantastic. have and having trial. her not I actually put in disease. will the most my potential patient been I the in this and how patients experience about my And for Talk my we who treatment in I can in bilateral there. But eye a to the But trial are who still is, eye. has are eye

So fellow happy to receive of absolutely will eye trial I it their than the have in patients second think disease who be more my in all eye.

Laurent Fischer

And Thank and very that, peak NHP an in recalled special level. you, still that Dr. showing pertaining at you safely did do as obviously of good response we see could the study we Khanani.

hear - to planning we're studies to in And the So that's future. to potential look bilateral into look exciting very the that.

You presented received how Angiogenesis colleagues? by was you Meeting. data the OPTIC your data latest Can me that tell the

Arshad Khanani

the thing Absolutely, not the routine presentation. and colleagues I special and Phil is, can we number a the think is intravitreal an live one that approach more is all we Rosenthal, have My without had seen. procedure saw that you It intravitreal a world like Dr. pre-recorded needed. setting deliver question than fact can that was approaches a that raising us that you office this other obviously the of having deliver in around any it are skills injection favourable

actually any same and Dr. was So mode why soon Rosenthal. other my look the partner who delivery it is my gave of at would retiring said, anybody I answer

disease I now? and now? continued learning they're patient efficacy patient gene think well. that the phenomenal. present I this the therapy And times control disease the on guess they like I many control the the I doing think all really, chronic treat patient course intravitreal think about look efficacy trial is time can really obviously the not I initially we're case, the when we're the doing still with How's doing because for world preferred still patient how's really around is And but we of every is patients so at of only disease. throughout the approach the and case, impressed what the

terms there's injection, not be incremental who benefit. continuous easy because to patients feel this involved in an power So in we to research, see it. to value single It's been in-office how this of want I part the a they're then the with want do the manage of be game It's next trial. the lifelong disease. colleagues efficacy We delivery really like we like that and changing approach has impressive transforming this we very think and of my we

think colleagues. to So when excitement clearly is the talk I I there my

Laurent Fischer

This is good to hear.

you faricimab a of that you enrollment X,XXX talk trial other XXX and So other patient to in study? talk patients that in require about you do previous terms you enrolled Can see may patients trials over trials anti-VEGF Did the about Let's anticipate time. any patient if short trials How in enrolling actually surgery. hurdles? compare going? like this that

Arshad Khanani

How the in are trials? going So right? sites question, the is, about going have good is the excited be world at site for in And a of competitive faricimab. course we research I were this of for investigators because always trial data think on to that's next top the to exciting with of top landscape trial the Yes, and we study question TENAYA recruit?

very, large top tell site the than and months very, community, space within those a I for you are as is large. we the less especially DAZZLE trial as and you, KSI-XXX We can trials those XX mentioned retina the for TENAYA enroll the study at

So data not solid OPTIC trial having having patients for competitive trial. this naïve from another

there's can in think on AMD a excitement this of be top we I all want of my to and less recruit that very site patients able confidently the this us or naïve to suffering being should we many the based one-year going sooner it, I take experience participate disease? around will all and this treatment said to for we good are The trial this think the I I to have for in study going it's can and help within be world. chronic our patients. Who sooner trial think, patients from our be

Laurent Fischer

you an also to partner developed. and like for do methods what to talked procedure injection? surgical excited Can that you can IVT through either delivery very it's we're we subretinal to about and to as soon different look gene to a walk therapy with for start us compared the We doing and globally. study enroll injection Obviously, forward as approved

Arshad Khanani

then different as look delivery at for and patients at efficacy treatment and researcher our options options I mentioned look those Laurent. job approaches. It's different as clinicians and to of Yes, our

for an subretinal well dry approach. know, Gyroscope I'm I'm you a PI as PI and as for AMD, for So also suprachoroidal as well investigator GTXXX delivery [indiscernible] as

Your hurdle question to going after than something something obviously you in procedure. experienced can approach delivering about OR subretinal a is that have But perform office. obviously it's you that an bigger

patients see and patient the them clinic today randomize I and screening if sites coordinate just have - too. a pre-op, one them looks go off that's go that and need have Delivery to for a in to gene staff ready, the to a to can a I'm therapy a I they we trial I to trial subretinal is say OR, of patient have do have their needs Port which if then System stay for they surgical good, the top our that be everything anticoagulant for were and I and to the let's So versus not bring also we have to

want to surgery. make coordinators arranging obviously and on task my in much everything and have the right, patient they coordinate a to you're when and surgery available to so schedules go staff their having for then sure be companies bigger is done surgery So to obviously is

doing and obviously a So have yes, you people easier. clinic the on they'll that's yet it data be whether used around the going to a suprachoroidal, don't specialized obviously intravitreal that, problem. it. anything on procedure need we it's meaning and as and doable suprachoroidal it's in But to any studies are or it's know train are its not world not But

Laurent Fischer

an see clinical world the many impressed the see studies injections treatment you about of see, to great. standard know you're involved regular the patients This option? good trials. to as great how current do with so bit We and these an shifting about you only XXX How current can on is that really investigator potentially you all in as it's to have bring real paradigm I'm our is from Talking of versus future. a data care not trials. top something follow-up

Arshad Khanani

patients the four, see well they look slip I do and in second sure start five, long-term. fine Laurent these to that's year, seven what patients Yes, that to you the I'm We year treatment, at want six, they first my years. get then after. things in do make

seven the have we seven years about comment treatment with up These have I'm want You issue for data, course I'm this a my lives is biggest know clinical because of you we long-term involved really and vision patients I'm end And for involved almost up at patients cap poor PI burden as now, and everything and is being because your with serving our space. space for better look time everything trials. but exciting I to XX when make our study.

two You divided into options buckets. have treatment to

you have an and terms to You of durability. where do divide treatments can injection incrementally intravitreal be better in

programs So delivery case the control is you disease forward for or months then or have great three can continuous sustained we that and difficult injection two those to very of that's delivery. The you top my part intravitreal to month a can other what moving But in which saw add that's lead know really I patients you and [ph] is which with that the exciting. presented. faricimab achieve are and on and months things like and GBXXX KSI-XXX

own primary controlled look surgical a I Delivery you paradigm it these procedure the for see that see risk when benefits the shift patients that's we and in its has after but it's a it's happening. has and I System treatment So what treatment. that, is Obviously But primary as Port disease. a really OR, their XXX that not is, so at started have

for them idea. then us patient get But therapy obviously up XXX. go I with naïve a see trial patient more injection if clinic intravitreal gene that primed the will course give Of to in receiving disease, into have my naïve and I'll an do

burden with easily So I think reversed long-term approach. outcomes with be this it's disease can a treatment poor and chronic

both from You those benefited and case of these real I this really saw the patients approach. that cases have presented are

Laurent Fischer

explanation and when Thank clear you, to thought that's availability you about was wet at really impact DME? global think the about level have of potential treatment a of Arshad. of particularly That anti-VEGF going Any future global great in the AMD. on

Arshad Khanani

Both Laurent. don't world, huge, in mean my you resources be you or I you the injection. and I look AMD look in DME. have manpower look India, the mean to and every Africa. going other see vascular they it's at think I have month around at don't Mexico, monthly continuous they deliver at you to opinion

these Here, injection and to single not chronic you've and diseases obviously initially process. we is modify with monitor said, Aaron a continuous as patients can these a this lifelong

anybody I would be once can topical and they're finished Telemedicine COVID-XX drops these afterwards. because exploded controlled. really they've of think their used. and Telemedicine has monitor patients

dosing, then after forward think around But to waiting world month, so that not every looking these because month in. I mean I every about after months to the initial monitor. want they treatment six access. think don't If months. patients I'm we have other or come for the they So maybe every seeing

You be going because physicians have they therapy help to really to treat to the done patients them and able that's continuously. don't treat patients have one and more

So manageable huge, as I in we've this continues think and good if be then uptake going efficacy the to seen is to safety. be as

Laurent Fischer

want actually much Thank you of That questions. of being some have our so ask to Dr. Khanani. you to advantage take is I great. here audience

them. direct the So call then for I'll questions maybe open we'll and

you operator, questions. open call So for if can the

Operator

Please from Sachs. Goldman go comes [Operator Graig Suvannavejh the question Instructions] first ahead. with

Graig Suvannavejh

This It's again. great for you hear from Dr. is question to Khanani.

then I last a and then just we are just the data, think timeline? there this DME if those be current that on than the the to some the one Laurent. dose around follow-up far of thoughts dose do the more to your study the in you from strategy expect profile more And from need and get protein and see waiting with takeaway would and you feel was different wondering higher moving to update on program wanted doses OPTIC with lower two perhaps do we've perhaps perhaps different What been to would question company's or comfortable there DME. from specifically, and of question, for thoughts with Just that I be I the seem an dose see thus wanted ask was that you evaluated what two a to those importantly, expression what doses? to and three. if Thanks. What could could revisit

Laurent Fischer

Graig. Thanks

I it to Before on Khanani. pass Dr.

this the I we will with our unusual injection. with the we've what's so had to dose additional XXX% last study the is that, no need know started think it actually anti-VEGF it's we patients dose, first program population about for important be hard-to-treat thought of in that,

So we response day a those curve top therapy dose know, we the and gene at the of as started are fairly in flat.

will answer that to a patients as now first around provide really But drug need straddle between I'll Dr. enough let was we in believe anti-VEGF profile. good a dose to we line more So far we've therapy demanding XEXX dose what and to seen great less provide response as Khanani, thought what going detail.

Arshad Khanani

and Thanks, Laurent nice to great, from obviously. you hear

and the think going XEXX I first about is So your XEXX. strategy question

my in approach XEXX. opinion efficacy that's have great excellent think with an I we because seen

the that can I five both with who cases actually you very weeks. frequent injections these were to every are of see and presented So four today from patients are we are controlled XEXX in not

as their need really tough then and to to efficacy of very of expecting disease potential XEXX remind with history were population. pre-treated ourselves So I patients that from I and we treat fact think think Laurent heavily these longstanding the said, I'm

and So pivotal to at overview and since Aaron sooner have in you going really population based naïve we patients treat get. fresher the are experience control you're and patient, patient you are better looking our nice the know as the mention the is those a

population a can be I can in easily see So that beneficial. even naïve XEXX

and of people opinion obviously right trial. having it's So are both I this involved doses decision think I with the my who in think terms in designing

pass on Aaron. I what to comments mentioned? have I'll So you top do it any Aaron, of

Aaron Osborne

that's we've with seen that a anatomical great the mean What response there's seen longer. really we've been strong doses. think data we've safety and of with both tracked favorable right. profile I and durability the both I doses is a longer those exactly No, of as

sort you DME. lower back great us that. the think surprised dose that look flipside, other kind may patients XEXX almost aflibercept patients after receive there optimized ability I two two by bonus high to dose which already We've three It's dose. signal about protein if few And correspondent that who weeks possible We're at VEGF of higher treatment is evaluate in data the the to we're presented. are of Dr. expression with that a those continue Khanani benefit from on continuing pleasantly dose, by presented injection. has evaluating going really within the high blocking this with indications from that

those acuity data. treat is I of stable, we'll look got forward, these anatomical expression - and go think we we As again you visual we've patients. protein lower more expression dose, response that continued that certainly just how as and But rough present idea at are data given and top in the protein to robust

straddle going they to the we to provides good approach. alignment with a XEXX in ranging discussed doses and full XEXX seemed to additional optimal for an Phase dose two So that something X and and were have agency seems some that that it's approach be that at XEXX

Graig Suvannavejh

And maybe just DME on timeline?

Laurent Fischer

half the which potential DRSS obviously to given DME where have going top we're is to well is Cohorts present and XEXX and study as all And go we or expression data. is data have fully as mature have X information. potentially We'll obviously We'll side who then in blinded. as large one-year Obviously at [ph] a data Cohorts report X. second [ph] and report DME, Cohorts And X present one-year and DI enrolled. they into continue both on as in study line as once in positive. indication studying protein we'll including doses It's risk data we DME to soon then we'll we're look being this the

Graig Suvannavejh

combined Fair filing strategy? to sNDA for an a it could of assume, be instead sBLA

Laurent Fischer

data the [indiscernible] to ophthalmology the other have obviously to we Currently next then indication discussed the they're case and move division have by can a most of different each once INDs two separate question plan to Any forward. and and otherwise move we be we treated indication that's for caller?

Operator

The Buren comes next ahead. question with Piper Please Tyler from go Van Sandler.

Tyler Van Buren

And follow-up should that or minus criteria the slide could and we patient is wanted newly these supplemental or similar related you it was somewhere up assuming lower doses? that as diagnosed well non-inferiority Are this Could vision there? margin assuming second be at said injection around then four as be on the confirm topic picked OPTIC. helpful you the the that bound design. be to of question to if on to the population to for First thinner deviation, the

the not same. maybe So exact

it can handled will be just I will So analyzed it if be supplemental what will guess discuss the be incentive and PCBA exactly you of maybe how treat injections? and independent [ph] change

Laurent Fischer

I'll Aaron Yes, Thank question. this Tyler. you, let answer

Aaron Osborne

to other Tyler. Thank and of that naïve you, non-inferiority This aflibercept study will letters. treatment non-inferiority sort will standard of study the in be Laurent. against It care four similar Thank be you, margin.

So that estimate means four into of be letters controlled the the the ADVM-XXX lower acuity confidence visual point bound related arm. to of within both the needs for

So get Where that's per used different in before. than much is on number spend of to being bit that little we FDA established with time first there previous is trials kind Which approximately how this, less arm number. and we're gains is a trials and standard actually several kind experience And the injection. is lot following a are the by of has often the half to your of part visual driven that we the acuity which second goes question, deviation. in

injection anticipated need treatment that or their receive a who they what with naïve. have point. are for an then patients treatment that injection for one response at do share to and then ADVM-XXX. this starts So take They to plan provided another actually They'll future study, and and we baseline need is receive

a is which gaining on initial visual acuity up lot still variability the then of gain that's means has place has reduced. of the already average. So phase that on taken But

faricimab the study be typical significantly [indiscernible] Dr. deviation Khanani it treatment naïve than for that or the as mentioned. study So standard to would lower expect be a such

would So those the deviation is lower study. standard than it for be

the deviation. standard non-inferiority So and that's the

I [ph] and balance supplemental avoiding in similar seen anti-VEGF maintenance patients that going get to and minimize see anatomical we needed want obviously I administering trials. to any visual maybe acuity making between the sure plan because that possible think whilst outcomes it's are the best changes really the always there's striking not they suppressional final question that great was are those these constant rate going a acuity injections OPTIC adjust visual in on mean treated to also maintenance pivotal criteria. background. the retreatment optimally We've to OPTIC or

We've So we reaching plan final before similar to got very bit to protocol. keep little time a these OPTIC. very our

don't to get So anything from and particularly the the monitor We'll expect to and ex-US closer precise in OPTIC speak little different we'll But as bit until as we well. the final a details physicians wraps OPTIC. we keep regulatory particularly data continue to under time.

Tyler Van Buren

Very interesting, thank you.

Operator

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

Mani Foroohar

investigator the only towards patients see - across more what patient period. terms a which ease influenced how got across of wet a that's results pandemic you've in mainly Dr. question here. we I goes trial fewer less a of Khanani of Obviously, AMD is for trials little pandemic office your enrollment How coming behaviour and lot and seen and shift down. the around see given that I'm bit want the use, changed as could detail you've nuanced of your patient as during afraid

you view, trials other you during Xs population were think part in the being were versus be, currently enrolled that might of enrolled do of two clinical how that that Just population pandemics? actively that Phase the that height of impact in in perhaps gets terms the of enrolling

Laurent Fischer

question. question, great for the Mani, thanks

a As this in the change COVID-XX reminder, study today's which and remotely all is Dr. - the in question future. months we obviously fully this into we during best how how enrolled was about changed Khanani thought pretty in has six But will remarkable.

Arshad Khanani

Thanks Mani Laurent. and thanks

get think treated, so out blindness they're in go a thing And can I And is AMD to main disease you don't irreversible patients. blind. point is them going the to that if wet to that lead

terms been really all of height we've the trials in as taking the well pandemic, in at throughout the patients the our pandemic patients. been even AMD of So care of wet good as

patients with very study COVID can patients who me way, to that follow-ups were after really, a managed putting continued where unique them visit, well. with and provide Also we we our we hour visits, cut in really worked have in routine isolated visit. protocol able were down So injection we

don't those it's some our on see So it to geography the because them were put trial. emergency because AMD population and patients enrollment an atrophy in hold improvement get for stop patient on trials a wet into trials other didn't of of

I So very pertinent. us and realize tell has have made think question But trials is you AMD what wet I your done well. COVID

six this diabetics. every or patients pandemic. As month every during high physicians, we in weeks also have cannot are risk, the patients coming These

we're situation getting for to them pandemic where risk we is us our for time, put fit therapies But in to a so our by and of heads has us forbid are have really ADVM-XXX So perfect that terms sustained or have over god our clinic to in long a that's clinic. at actually having I putting don't come because patients of their I that down why having COVID. have bringing in or to ready now. another treatment that cater see received enrollment it ask see Most we one dose don't clinical a terms numbers every our patients my all actually trials. really to really of of to is gone significantly that the patients trials and in these the trials, have in pivotal first vaccinated also promising difference enrolling single have area and in in the patients been

be appears towards going in are hopefully to getting normal that the really things future. So

Laurent Fischer

a the more in have few analyst queue. we know I you. thank Great,

try them, we Mani. to take So thanks

Operator

Your from Nadeau & Phil comes ahead. please with go Cowen Co. question next

Phil Nadeau

from questions Couple us.

on and XXX First dose information. the

did I for I steroids? all think correct, you hear that in could if how And so, us whether there's patients cellular tell therefore at recent time mentioned that you that long? that? of information is most no the And dose point,

Laurent Fischer

take want this? do you Aaron,

Aaron Osborne

I inflammation, specifically from we we've that were of that eye that did steroid any any consistent the the that, low The steroid most looked of FDA can October presented went last taking Angiogenesis. recent taking course. take dose seen and We patients - that cellular the data into yes, our and cellular at have that's a really were data on everything at inflammation the and had who we drops these is presented drops sure that patients patients three data numbers point. signs that review were we of year of no at data meeting in and

the period showing really great this of the to prophylactic of go them We're the efficacy. kind steroid both doses decision the seeing with after a steroid minimal cases later been and prophylactic mean drops, with who with needed two to I eye low few XEXX dose drop after inflammation good where and minimal around patients into onto back a high little So really whilst use plays as profile period There's - eye that that dose. safety wears. go well

Phil Nadeau

visual aflibercept acuity on, your arm. be second It Great come would benefit did it and more for does assumptions question in the have the upon How then patients And to seem comparative what is match you generally of how full you're get? now the visual risk dosed? arm and I'm assuming is some whose that dose, like in in going full year there's dose their first to you actually acuity treatment. improving controlled at aflibercept

able that? confident you'll achieve So that you be gives what to

Aaron Osborne

it's great Yes, question. a

for standard comparing complete label, trial. the That's comparative three injection naïve has faricimab as So been for aflibercept in what initial of we'll to regimen that us standard eight the recently trial case patients and dosing which every weeks. is followed [indiscernible] care treatment the by be

confidence would able that. that gives what In terms of we achieve us to be

the that before you seen line is or it's that anatomical of improvements a Cohorts I all not and steady look X it's free you follow-up, these really in frankly think low with seen with single When I data that require is The injection to therapy. what we've the difficult we've vast throughout presented at have injection treat rescue CST and and many remained together it comes X inactions. think dose extraordinary single today. back point to something patients treatment majority on constant that that see

we're VEGF cases need visual well as actually suppression as of Really, some So anti-VEGF we in that do seeing acuity therapy. patient the gains. continual means to that and well is has

better doing is I some than therapy. OPTIC, think seeing that we're what in patients anti-VEGF are regular

that we the will the predominantly and is show set and have So up than the what restore that's a follow, anatomy visual acuity us the trial gives retina all stabilize is should improve that. confidence and to can really we

Phil Nadeau

last then Khanani. and Dr. question to just Great

any approximately and practice? injection X are meaning back? to disease patients Are your that free. look free are can How we've in in are when if How the or profile monitor in patients will of say Phase signs there remotely Let's return? you the looks for injection patients see you process seen dose XX% bring exactly XX% what else like this them patients having

Arshad Khanani

Based see Yes, the have learning's so initially. from more we trial an that's OPTIC these question. excellent on as then patients to frequently,

cases inflammation see once say loss. them So is that But we'll vasculitis, reversible Remember maybe I the have within posterior there's of vision first in can retinitis afterwards will be anybody treatment interior a or think all months of monitored. here six the no they I month. to

that's to I in So something think keep mind.

with six like or comes in and can they I they have to have But be being easily me, investigator enrolling my if keep topical the patients else, an then and for number initial OPTIC can be So patients I of feel in months. that. I optometrist by in after needed much asking trial to they stable who coming confidence highest and if go in be to patients think years why one drops. these trials do longer. treated half the extend they this monitored But we I practice and we need can from can of somebody I once patients. course phase am every patients they're mean been and month monitoring

Phil Nadeau

taking for Thanks helpful. very questions. That's our

Laurent Fischer

then. more question take Great, one we'll maybe

Operator

Young questioner. more ahead. Fitzgerald. with one Please for The next time Cantor got from Alethia We've comes question go

Alethia Young

I the secondary the and importance of This weeks bit FDA or it's bit I as of maybe in kind it more endpoints analyses want, any Thanks. of Are a question. like probably way same wanted obviously I thinking to acuity. the secondary rescue the I question a there [ph]? of what other like endpoint. into talk feels doctors what second as some my about may any is is question guess doctor. an baked regimen about mean And correlated interims kind The mean a rescue little FDA first my visual little notion kind that's is needs. XX and to straightforward. a

Laurent Fischer

take you that? can Aaron,

Aaron Osborne

is differentiate forward. straight take a learning and more are to [ph] pivotal things data reduce patients and analyses, it's there no outcomes. more one experience look to would With the is and are that so because we long-term which we interim the atrophy key product be those about the support long-term can to currently first, BLA secondary of would endpoint fluctuations year either - trials lot these one with lead anti-VEGF reduce stability. there's Yes, a, primary patients lead vision to to therapy and to and better this more is to that the more coming one and or available ways fluctuations we're second outcomes. atrophy analyze the intent actually they can at potentially endpoints, fibrosis, registrational different data submission. can I to regards that fibrosis, fact that's through the you and Could lead those that lead to poor and maintain raised use a These they

on patients and functional want that what more we'll long-term. we of understand be also about us primarily to follow at to story so of anatomical the But need now we'll terms OCT analyses XXX That's with can potentially in outcomes. to up build probably And looking stability more lead let that number that say and could at moment.

Alethia Young

you. thank Great

Operator

This concludes would turn I back like to call any remarks. question-and-answer to Fischer session. for closing today's the Dr.

Laurent Fischer

therapy vision causes look therapy where this candidate for filing as that therapy hope enthusiastic and leading as goal great company I and global transformative clearly hard as you. new XXXX [indiscernible] rare become the work therapies last agency And everyone we're a thank expertise updating to outcome. very their heading to execution appreciate like day to important sight to Who for participated done the not our needs. advance to pipeline the trials. continuing journey commitment develop all a preserve want life? forward for blindness with as our and patients talent sharing of to and fully to We ADVM-XXX well gene want with of and focused gives patient but gene therapy our good patients XXXX with delivering company. continued building I integrated of to a treatment all healthy Adverum's. This patients is and around good during bring joining mission and to of unmet on gene incredible work potentially guidance us. team in about two IND organization they on investigating lead well. establish goal investigational and our of one-time an us. We're on every work I'm you the clinical been to acknowledge Thank with in really their our our the with develop the to leveraging progress staying an certainly the work thank operator, who world. We're has in the and also We least, for our Khanani proprietary you, patients the I to discussions. Thank his All I'd platforms future in day. the and ocular wish COVID-XX disease also FDA lead Dr. our you acknowledge

Operator

conference today's This concludes call.

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

Adverum Biotechnologies (ADVM) 2 Mar 212020 Q4 Earnings call transcript