Adverum Biotechnologies (ADVM) 9 Aug 192019 Q2 Earnings call transcript

Good afternoon and welcome to the Adverum Biotechnologies Second quarter 2019 Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a 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. ahead. go Please

Relations welcome, call. and is our quarter the second on at corporate Thank www.Adverum.com. press everyone, release conference Investor of page The press results of reporting XXXX our the website you, release to section our available financial

a today's note the will on call be that Please and website. Presentation also available Event section replay of of our

Officer. Patterson, Aaron remarks for Joining of the the will Medical Leone the Osborne, is Dr. and prepared Leung, portion Leone, call. Chief Chief for the and Officer; me today Executive Thomas of Aaron Financial Then Chief call Q&A Officer, portion available be

a activities be XX-K statements to those risks As these regarding research and statements operations cause forward-looking and uncertainties as risks of the are can subject that our our on be recent results file from we in These materially reminder, may to well differ making outlook. forecasted. plans, our Form product SEC. actual description most development as found with A will financial

turn like CEO, our Patterson. I Leone would to over the call now to

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new board industry Finer from the Directors focus on has member Mitch retired Board and role. co-founder, First, of to a

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Thank you, everyone. Leone good and afternoon

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present Medical the the the the and to at Meeting outcomes In podium will Research OPTIC week of London. during mentioned on Turning the Director clinical Phase at XXth ADVM-XXX College of September and presentation data Professor Retina presented from AMD Society Leone of secondary XX cohort primary of Clinical will Associate a the X X Szilard first Ophthalmology wet data Kiss, in trial Weill as be first Dr. Cornell patients. Annual

OPTIC had vg/eye prior the single frequent patients in for of to AND, enrolling their at at four wet X intravitreal were at who previously dose given These injections injections in at baseline. a months all injection X had x required received XX^XX anti-VEGF and least a ADVM-XXX

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observed have previously DLTs cohort have been of in we first and this FAs no patients. shared As no

this objective cohort primary week and outcomes XX of we safety of the presenting As for will be tolerability OPTIC, patients.

the saw robust of the second OPTIC for have lower anatomical to of cohort. cohort We we response previously the preliminary vg/eye shared also first dose a that to led our which in XxXX^XX use decision

important us from both ADVM-XXX. potential injection the and following a The intravitreal endpoints assess help single secondary anatomically are of functionally, to benefits

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million the the the and among million Anti-VEGF is in reduce effectively are X of adults only in U.S. can diabetic with retinopathy. the Diabetic age X therapy are million risk diabetic cause side diagnosed events of edema the X other only diabetic overall people macular treat and treated. vision being Of loss U.S. threatening retinopathy can estimated working leading in retinopathy

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to half the development working IND XXXX. of are clinical the to ADVM-XXX and submit diabetic retinopathy in for We first FDA on an plans in plan

will CEO, the now Patterson. Leone? Leone I our over turn to back call

XX-week some at plans first for Thank cohort you, London. OPTIC data Aaron. details I meeting the annual for six want around to in Society add further presenting the Retina of the patients

plan broadly. we and the close to this a meeting, OPTIC Although, transparently data share is

We will presentation on copy available podium of release slide and by beginning website will corporate a A of after issue call. presentation, a at conference followed our webcast. call the press the be the the

With call will now that, to Operator? questions. open we the

Our Van from Buren Piper the comes of first question Instructions] of Jaffray. [Operator line Tyler

open. line Your is

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least to You injections mentioned four two the OPTIC. that the in months they prior at have

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Eylea that the fact simple the study. do they've Just had prior to

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the injections, stipulate So at protocol four injections least must two yes months. two we had patients have previous in that the in

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So anti-VEGF injections eight or patients require would of as XX% around weekly or four said at more intervals. we

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show Eylea, basis. They a can the ADVM-XXX protocol on have to because protein the Eylea injection Eylea in producing respond aflibercept is is to the and that aflibercept they sustained

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that that of frequent injections idea ADVM-XXX require summarize all on by that patients I potential with number very patients the should and good should defining follow-up to we reduce protocol as So those for your have that to injections. think we're answer XX anti-VEGF a week

terms of helpful. you envision, based that sense. And was on OCT that's injections, makes in which rescue Yeah, it mentioned

six such months injections is percent you accidentally more rescue can also stable? first or a those So that how criteria maybe little a injection rescue what bit in the would is as about over implied speak when patient that still provide win? doesn't someone relatively you what reduction stringent a magnitude And view

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may you lose disease, treat accumulates it's Wet that is I mean don't possibility vision irreversibly the the patient if with an the aggressive there's challenge vision. drops AMD then fluid and and that

and or receive disease then experiences if vision they injection. patient rescue to a due So stringent our a dropping Wet actually criteria AMD very fluid would rescue increasing are activity

lower just and anticipation see speak that with And oral gene that topical guys therapy you prophylactic do steroid just Can could potentially expect a general you Okay. in And would over to of that time? it you question tapering. dosing resolve dosing used you you've why inflammation seen over to move is towards go down that on the you think final due you days. XX the that could to would or historically steroid that dosing study with just

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patient specifically And because have six and off. immune giving milligrams dose is a we're of days response it that's, tapers there the prednisone. tapering So it of They expected. XX an then tapers yes, --

additional the cohort, at enrolled and the we plans dose currently, what the that's whether OPTIC whether could cohorts further therapy steroid looking considering we've because second regimen, move we to study, adjust add as that might be something certainly we'll mentioned, Regarding be for and whether the potentially well. we've be we would topical and as we

moment, data on the update plan more will and for waiting we're from year. second at So cohort to little this we really later the a

much very the questions. Thanks for taking

Thank you.

Nadeau Our next Company. of question Phil Cowen and comes from

Your line is open.

Greeting last questions. thanks inflammation. A follow and there up taking Tyler’s the for to question my on

intravitreal of be How less for physicians injections, eye. inflammation tolerance acceptable to the little physicians your gene any What's have opinion? therapy? For would in much the for the in sort sense intravitreal frequently information administered your

you're that frequent endophthalmitis which saving Yes, would very I of mean even rare risks I come having improve back as to the are that these such when injections and many poising outcomes as unpleasant World Vision carries as injections. got well point some can to an many, procedure, which Real intravitreal the It's although those having increase. injections patients potential risks

requirement reduction be following then will would look immune gene that's that willing everybody think in certainly a a response can lasting I get the long a some trade-off will to But So, people expect rescue at. for be therapy. if you there injections that

really it -- presenting the forward think we I to So look data.

required. September picture injections XXth, and and outcome think around -- the able the to tolerability rescue the I is that be as provide numbers a of around well fuller as secondary we'll might safety primary acuity outcomes be of visual the measures, about outcome which measures anatomical around on much

And then lower helpful. decision That’s great. your Okay the second to dose. on

reduced. DOT for you at initial was limiting the about why probably -- you mentioned what you that -- You toxicity no there's why Can the cohort. dose dose talk criteria dose

Yeah.

the dose. they so course, They met. the if be escalate monitoring in they dose committee, escalate events considered the adverse period plan to data to early occurred we treatment. to cohort. that had C following would have second data following recall was IBM recommended The any independent and first Of an unanimously you And the

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is response. the saw not establish We key that higher efficacy dose. that see incremental of a X of so wanted effectiveness recall, you aim doses. with dose anatomic be did different as could range, to Phase Because We the we robust trial to a this

decided achieve after to waiting to that. we if we'll So data the could and and year. we similar that down see period for to later the dose And see in of results, the obviously except we're types we lower in now dose. our findings recruited share We're the cohort

for fewer its to rescue to of be need gene But it you And if versus me, that the need where you've everyone you think still Is that profile, answer the does of reducing injections. by a much helpful. gets benefits -- play noted very just – the of last treatment injections, do The question That's patients it accurate the such burdened cleaner an just Tyler some schedule. think that patients rescue successful again you devil's decent monitored on a one What are gene better. would has product? diminished like a proportionate rescue do seem percentage question few regular therapy just the then successfully create who injections injections in or argument? advocate, that therapy

Yes.

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injections, would certainly the So that and And monitoring or would that how and is patients the subsequent beneficial. which back made, what deemed are predict they you significant the think any those going I to point greater that a to can be, schedule. which more reduction is the rescue reduction you be helpful, be whilst require to reduction, many exactly comes

you the the fewer lower can't the patients these and of make things and big have predict very obviously to those then all number of will if play to accurately a in the number usage. So into uptake it, difference the these

does that's a to think it back really, rescue number better. the why come ideal injections. of additional And to I So minimal have lower outcome would is be

That's perfect.

Sorry.

programs. give the Could Just one sense the postmortem vector was trans some What AXAT what wrong last awesome or was or went the prognosis of was program question the what you on the gene. diagnosis? the it to with the us as

is Leone. This Sure.

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some either last over could We time how had continue six those months in spent of programs. move to possibilities our the we forward reviewing of

to given I the came have we to development out as when got need is we a to We for a think retinopathy we AXAT will program AXAT. saw to better given HAE, we to led early therapeutic potential don't level. that that us that with. the you get where HAE back this that we to get that see, for believe explore continue you continue level believe however on levels way can through from is to therapeutic to if we

to entering we be what's believe to clinic So see want that we're to the going worthwhile soon. didn't possible, anytime proceed, we raise to still but expectations that's

that with but back stage. So the to move it's we to development forward how clear we in program, early could continuing were that, we make wanted recognize explore were people sure that that,

Congrats for my questions. Perfect. Thanks the progress. taking on

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you. Thank

from Lee SunTrust comes question next Robinson. of Our Joon

is line Your open.

question. and outcomes, something determine the therapeutic talk Can is the amount I will a least, in you that steady of that view anti-VEGF as and aflibercept determine based that range Is how right and Hi. follow-up. clinical part, or you Thanks compares you strictly have will at ADVM-XXX that you wet or AMD? state IND, much about what for protein from for based you. on how to Thank produced on

you Thank the question. for you. Thank

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risks if over to that specialist they greater fully the you are speak of under than think the treatment. I retinal treatment agree risks of

for therapeutic to of lasting So very is small It's very AMD. the across a coverage sometimes injection patients likely hard number require predict a be patient a long attractive to spectrum therapy that that those may only a can delivered provide one-time injections. anti-VEGF option wet entire with very

said And that's as small earlier percentage a as I on well. very

enroll and the ensure a the taking require patients care are risk. biggest the that those frequent the we're trials we patients under if that's I think that to bigger injections. So, Obviously, risk treated are much in

very much. you Thank

you. Thank

question of final from James. Our is Dane Raymond Leone

to forward looking …for data. OPTIC updates we're that definitely everything. And and

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primate the Now order-of-magnitude you're cohort non-human an dose dosed actually you've second the data. where on below down,

change So, the I you. about guess, translational in from what magnitude away kind you data? of that comfortable Thank made

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see really it's that could such we on So was robust that that response. a it basis

obviously is and broad regulators a doses Another best as X you've as purpose demonstrate to that the take trying to looked Phase for well other besides and to range. FDA safety ranging dose at forward, identify to

to the get that that additional looking at not on effects we're look also efficacy we see we when and tolerability. effect could titrate OCT, we did So

see time get but not reached, make clinical type the which could we've question decisions, of that timely reached, then us would that So help we could had that we is we not in the that certainly additional a development we early same really that felt point efficacy, point with dose. lower an was, if efficacy

you the Because if can to we magnitude, preferable providing or regards obviously, see three-fold. to is with higher went down number their dose. reduction And dose that, of a that to

up change to our is So initially practice gene studies. dose go And three-fold three-fold. in was common plan in a therapy a really

just anti-VEGF you not public just or or I the one just for Okay. standard equal whether promise. anatomical, does can very this, state final robust but everyone's confused And injections. been additional does response me about anatomical for not Obviously, call,

what times at You how injections it injections of of look on kind or isolation. reduce mean to OCT OCT. has not scans gotten world been specifically patient just a looking at a to you fewer the said reduce Does injection amount a that just that the like for of of make in is number clear you've rescue implying the

robust the full the assessing to on we patients anatomical on OCT forward of responses the these September. presenting So on and data XXth the of look based the

much. Excellent. Thank you so

back call CEO, Patterson. the interim turn now the Leone to would I

the September see We on Thank to you to today. I'd is in that data company plan our for a the milestones optic highlighted week today. time joining fourth quarter trial. our were This plan exciting first and provide again to XX from of plans the in optic of an the in year. patients for an the for update We call cohort this development trial upcoming summarize key like the

diabetic in XXXX. half XD a submit to plan of retinopathy also in the We first

optic lastly, XX data the plan data the the present the from in of week first And we and cohort trial fifth from cohort half of second XXXX. week XX to

continue We are accomplishments so mission very and with working gene Ochsner far we novel team of our and on execute to by diseases. as to advance excited therapy our rare delivering with the forward patients look to I

in like for specialists caregivers retinal I'd and participation trial. In patients, to the OPTIC the their thank closing,

thank your for I for commitment our continued you dedication to and also call. to this Adverum Additionally, the would employees concludes like the time Thank for the mission. and our

wonderful gentlemen, and disconnect you lines day. your time. may a Have this Ladies at