Earnings call transcript Q2 2023

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Operator

Thank you for standing by, and welcome to the Acumen Pharmaceuticals Second Quarter 2023 Update Call. At this time, all participants are in a listen-only mode. There will be a brief overview followed by question-and-answer session. [Operator Instructions] Today's call is being recorded.

And I would now like to turn the call over to Alex Braun, Head of Investor Relations. ahead. go Please

Alex Braun

today Good Officer; call Lisa. results welcome the Financial Siemers, Chief With to the Executive and our Thank Dr. Officer Matt Officer; discuss morning Zuga, our conference Eric me XXXX. XX, to ended Chief financial Officer. Dan business Acumen O'Connell, quarter Chief Medical you, our June and are and update Business for Chief and our

These to that section we from those Securities results presentation begin, statements go including and our materially listeners statements our of this statements the issued within could encourage to to differ website Please we'll note slide Investors the we Before that concerning in plans. outlook are conference to and risks morning Acumen cause meaning the subject forward-looking make the during to may find today. actual uncertainties Federal related statements. release press today's forward-looking the and Laws, we financial call, described business of expected discuss

Please a in prepared as Q&A. for our provided result or undertake open After our from of on future the actual implied morning press could filed risk our see forward-looking information that the annual or differ the no we'll information recent to SEC developments. release presentation accompanying statements. or quarterly with and factors new presentation, the update revise the this our most this in for the and cause issued We those important obligation X expressed results materially of to slide accompanying reports call results remarks or call or

to over turn the Now Dan. call I'll

Dan O'Connell

few today. for clinical presented support compelling ACUXXX, data ago of disease. everyone Thanks, asset who Alex. to Acumen and Good has weeks treatment Alzheimer's our joined of early in us the morning, A thanks

execution our convincing to ACUXXX's robust mechanism committed solidify proof results design study inclusive of top-line The enabled of and success plaque us in demonstrate reduction. treatment future I option as potential target Phase positive engagement significant amyloid novel the Alzheimer's a paradigm. Our assay, of

of index ACUXXX was of attractive shown substantially to options dosing be this development. extremely our therapeutic like investigators clinical our expectations derisk and our phase these our caregivers would our best-in-class safe treatment to important staff proud for their a its in believe stage advance results We a field. achievement thank and and I'm and employees, with ACUXXX potential team's and broad for asset asset dedication this beyond to at with in development. as patients next

and Investors from with INTERCEPT-AD already presentation so encourage our of not website the have results. section to you done view July I webcast top-line Phase I the of If to XX trial the you go full our

data we committed optionality firmly provided forward Phase the set. are harnessing by Moving the to I

have with in large knowledgeable drug a experience clinical and regulatory development. Acumen pharma at We significant team and a CMC depth Alzheimer's

data INTERCEPT-AD broader is urgently positive observed both the integrate the our plaque priorities. to ACUXXX and including our the reduction working into clinical Given plans rapid by future, trial our strategic team findings

biomarker in to fourth We study continue the data expect this to data quarter. from be and available the further analyze

our for Eric next clinical doses will We our trial are also finalizing which discuss.

II/III analyses. interim our PET Amyloid made have as such design planned modest changes plaque ability incorporating Phase to reduce rapidly into ACUXXX's We to given

potential which BLA a II to of disclosed, we Phase Phase inform previously II/III expeditious interim to our route a filing of from study, approval. potential and most to incorporates the the Phase believe As analyses the is design the study expanding a size III

design this end Phase fourth Phase II/III We meeting in FDA continue II the to to anticipate an quarter. discuss of the with

as of we attractiveness recognize options. As of patient of mentioned of XX expand our on viability mode to potential we this call, subcutaneous dosing are dosing July investigating administration the the ACUXXX

share to on made progress to aim meaningful later this have details and more have this front We year.

continuously are with evaluating we opportunities also committed should shareholders' and that Acumen development and strategic align exploring that are advance interest. partnerships I value-enhancing ACUXXX's to comment

would the Eric, toxic the the Before clinical elevated to to field. of engagement forges selectivity like turn soluble bind ACUXXX's our have in emphasize CSF over potential brain terms profile high degree to We to Phase call target to believe AB ACUXXX's into I efficacy. the confirmed in the in I oligomers I which results assay, by our differentiate

with asset's ability our months to three Monthly deliver provides efficacy. anti-A-beta to of in weeks forward approved as momentum ACUXXX's and we intend further point We review months with against our derisks and we priorities results progress only you execute look to under the plaque ahead. and dosing important strategic currently significantly and another sharing the operational differentiation. in drive line significant timely from potential believe reduce these in antibodies to

With that, the Siemers. Dr. hand call to I'll Eric? over

Eric Siemers

Thanks Dan, everyone. morning, and good

to As these selectively believe We our provided can ACUXXX our target efforts therapeutic oligomers. clinical for top I'm A-beta sure disease. to we best-in-class tell, you developed important antibody very toxic results pleased monoclonal develop of Alzheimer's are results that line mechanism data a INTERCEPT-AD a support for for proof

bound are per every by two demonstration the weeks. dose-related amyloid rapid weeks to measure very CSF, of plaque reduction also per kilogram every kilogram to four our and doses, oligomers XX target our milligrams encouraged of ACUXXX in addition XX at In the milligrams higher engagement we

further development the demonstrates positive plaque brain slowing XXX's approved cognitive case is a point at time relationship comparable appeared similar of plaque to soon and to evidence reduction The between activity a treatment, the and at three starting or around the be in established after robust reduction Plaque a antibodies months. in be monoclonal given rate decline. of finding of to approved reduced this

bound exceeded also in assay we You novel XXX oligomers as by robust measured that data a dose-related XXX demonstrated to presented by the that target developed Acumen see engagement will expectations.

our about time we we This engagement. is that excited has observed In particularly antibody a demonstrated finding engagement. target is an fact, this that doses the target that maximal are approach given higher first oligomer-targeted

with provides the intended of ACUXXX well seen in safety doses of no of engagement pharmacology load decrease overall, tolerated plaque substantial the with demonstration of at drug-related clear and With proof and Taken SAEs to regard ARIA-E. rates and evidence higher XXX low central of mechanism. together, oligomers, was target

Interestingly, our XXX monthly this six who observed, and with we homozygotes we the And in to other monitor AD. next pharmacokinetic APOEX in compared is and monoclonal finding not observe study as who were study of participants, did continue potential supported. to antibodies were ARIA-E for on dosing based will differentiation dosed profile a point

valuable information to dose provided next the the program, phase decisions. design INTERCEPT-AD Importantly, selection of including required

arms. Phase currently in are of study We X modeling doses for our the process

per the range of provisionally of a to considering in kilogram We dose XX a XX approximately mid-dose are high XX have and per XX kilogram. identified milligrams to milligrams

would in algorithm we be our curve are These target a observe targeting every potentially that that with area lies because Oligomers. confident robust we an modeling at regard in where four-week Emax is target location, engagement target to mid-dose our are engagement engagement can substantial This doses in occurs. and

it on Based data, at will plaque higher our study. Phase in X demonstrated result X/X longer-term dose that in a the lower is be reduction in Phase likely our reduction study believe plaque dose plaque could we the reduction and

field Amsterdam broader attended this the meeting positive. sentiment Finally, we With in in Association space, monoclonal Alzheimer's Conference was the International Alzheimer's as of general the one very tone July far and the as seeing disease-modifying achieve antibody approval, traditional successes. now now therapies attempting likely approval disease, a develop the Alzheimer's after traditional FDA to decades for is having and antibody to early of second

for disease step further new Alzheimer's a treatments disease these advance substantial hope for We patients treatments as are not represent they by best-in-class families. cure and disease-modifying Alzheimer's to option. While for a Acumen forward ACUXXX a developing at treatment

over call Matt. I'll that, with the turn to And

Matt Zuga

you, morning, Thank everyone. Eric. Good

As be we results this filed reminder, later XX-Q today. are quarter our press morning the will a issued in in and XXXX that our second financial available release

XX, approximately securities $XXX balance and cash we sheet. June of had As in million our on marketable

follow-on announcement Following the positive $XXX.X proceeds we offering, approximately our mid-July, closed in X which in of results million. Phase net upsized brought of an

Our hand of and XXXX. the expected on support -- activities into second operational current cash to half our clinical our clinical is

that we enough Importantly, have complete X Phase runway we to stand-alone believe study. a

rates by our as other the of clinical risk trial highlighted enrollment in As could timeline typical be course factors development. clinical variables this affected and in is

in primarily expenses was other quarter approximately and personnel Phase related costs prior clinical quarter. trial to related the the during were consulting the over items million increase to increased the $X.X to I year second the which completed XXXX, due R&D of we

million in $X.X million related in to from of were increase loss over quarter. year, the primarily This quarter operations expenses with a prior the $XX.X of result the consulting. led to G&A the personnel costs the and

our asset Phase value by the strong will our following we the We remain deliver as disciplined our positive clinical I capital results and are program support ACUXXX to patients to shareholders. advance and development the of financially encouraged and use for for

Operator? Q&A. for call the open can we that, with And

Operator

of you. our question coming Colin Thank from UBS. [Operator And will Instructions] today first be Bristow

Your open. line is

Colin Bristow

okay? me hear guys you can Hey,

Dan O'Connell

We can, yeah.

Colin Bristow

morning, taking and the for question. guys, Good thanks

approximate again I how just any you perhaps to differentiation the was now profile sort to what points done additional close And can or sort top months you. lecanemab? of maybe which expect through And what of of can mechanistic line? be share Thank just expect to CSF sort X XX and anything So and your you of months? you next to is over take updates XXX, to see just plasma since us? biomarkers then analyses and with since we maybe have if have can just what not, if analyses lecanemab, you wondering, And additional a you key us referring versus the

Eric Siemers

great. Well, Yes.

as biomarker question, really Eric. prudent as is far And this question. the a So, it's

know, that, developing going appear the are is send off said well CSF all to most field promising. the you we And be and that rapidly biomarkers a the biomarkers and we've carefully to As along plasma field. follow

the finalizing ship at come look samples all and later didn't results in year. will and process at we've biomarkers establishing those we're the results the so the we to what is get And did that in to in But the the we of have time done, now contracts prearranged study. to

right look we'll be field to the things in of at So promising the that kinds now. appear

of especially also know synaptic is a reflects lot because with because a we're attention. the A-beta represents think CSF, it XX So it plasma receiving to P-tau in function. be We astrocyte that interesting neurogranin you P-tauXXX XX function in probably of along receiving is GFAP, very but ratio, could lot attention

be samples and we'll out for CSF the those So sending assays. plasma

People drug was got but likely. results, what this that terms a drug necessarily doses most so anticipate short study. of In of it's and at see we not would might possible a three effect we

to So in studies doing this assays the provide will biomarkers in crucial for is the next development very be the these for program. actually experience biggest those study reason when

turn the that is to Dan. assays these just to we'll With apply So effect to study. but drug important we next may We experience regard one have in this with I may our the a study. to see thing back think not differentiation, then I'll

Dan O'Connell

Sure. Thanks, for Eric, and question. the Colin thanks

the and push of those study, And be provide in both concept this. I also looking proof to is think safety With some we're in study the path the differentiation really maybe oligomers and and have toxic important that coverage clinical towards to but terms to -- over most basis INTERCEPT-AD those importantly aspect lecanemab, A-beta of will next ability efficacy. at an dimensions supported for therapeutic being one of registration. the a better of

think, general oligomers oligomers is roughly selectivity for for and we over XXX-fold for XXX I And reported over XX-fold the fibrils. selective selected as monomer

terms we're field. that, in But of we're ultimately, differentiation would or safety obviously approach really the and that a point taking looking that we profile. demonstrate think key better the is efficacy to clinical within of drive to comparable benefit be So

Colin Bristow

very you Thank much. Great.

Operator

Thank for next our And moment Paul coming question you. question. of Matteis And next from our Stifel. one is

open. is line Your

Paul Matteis

from weeks level? the drug at the reduction What this had this comments, you that taking in board other Thanks I from hopeful of still prior you expect you Hi, do comments in every relates that in plaque mg saw trial You kg study. I obviously to think XX dose wanted around per sufficient out were XX levels to dose as monthly. talked plaque for three question. data you're reduction to XX you planning. my in once-monthly it made clarify think there. that to exactly some were supporting earlier week I on about your And exposure CSF that

monthly, pursuing why but the And plaque to as other there well of gap dose wouldn't match on A-beta this expect for reduction some encouraging you're so what's of the that guess I antibodies? you certainly

Eric Siemers

looking Yeah. take that. the We've a range work This lot at Eric. but narrowing point obviously we finalize is And next as down I can I the you are guess we spent for doses haven't of out, those. study.

people few but why this of Phase was and post-dose out is reply PET aware a an let's the there of need theory, we scan in when and of that's We that? anecdote, what was to a do study our one So INTERCEPT with target find little you study said things first plaque. my bit don't the be I Acumen there well the And the happens. a designed

we development And going you so lesson higher that what the I the results. generally we is saw when look just did have to reduction an we got see think results at this those -- for but drug the data, know it's important are doses. plaque expect don't to for you be, And

actually And what our even exactly so do really for in both going next that's doses study. we're to

XX really plaque a at see data, at reduction our that think on higher I the dose, we'll At we So what see weeks that per high we every have but INTERCEPT reduction a dose. the that month, three with kg, dose higher based only of was will total pretty likelihood lower mg get. at per drug. so XX got we mg some two administrations of but We every plaque kg

study next the be XX So months. will

So it at will And be a dose. that plaque to see we'll lower will what longer happen study.

least -- necessary for The again, view. our at plaque a reduction is to have but Now our not original is target bad it's us actually thing, efficacy our it's not merger target. or that's

And do the get to -- think the to so is it's studies results. like I this

and we'll II/III you about question dose see to that's way, But this a lower whether an need all so clinical on. you reduction once And is what I at or Phase point. efficacy starting to think it's plaque into be really the either get study, focus not, at open

science the on clinical but we're to be great shifting do We're a sort also the some emphasis measures. it's going So experiment. going to it, of where to of is

Paul Matteis

think volumes range Thanks, of test of know then some the the I it's on might on Eric. and also in Okay. early terms work it. at modeling Appreciate you different might injections? frequency be just preliminary what but drug And the looking you based subcu. potential one your question of do of you

Dan O'Connell

think early I'll Paul. on mean I Thanks, for it's those Yeah. a hear -- details. the comment I that. us to little

feedback. a Sorry, there's little

I we quarter So XX headed. We've available to anticipate since to where in good subcu we're the work do ongoing. insights dose be -- XX that not or mg got this a format. fourth do think kg of is high the per

I but precisely I we could with on fourth have how we to the we'll on plan think that, clear I be and proceed expect but in do the -- details more think the subcu quarter.

Paul Matteis

Okay. All right. Thank you.

Operator

Tom your for from next be of our And Thank you question. question will coming BTIG. Shrader

open. Your line is

Tom Shrader

Good taking morning. call. Thanks for the

has screening the your And you'll think a inclusion of from the appealing you then Given once you some do how XXX plaque the a trial? of next are to robustness level oligomer saturate how those in assay interested is, gone? you get oligomer for need And data tau. do trial to is binding second

untreated tau. between if increase and treated Lilly think suggested screen shown separation you you I really can has or the for

Eric Siemers

much. an very something time Tom excess person but target a spike it from I question. sort goes then One I detail a a terms signal. through that whatnot a little mean get you much And and give spent take the that it it interstitial point engagement assay, and a with thinking oligomers, intravenously thanks you if obviously on think the is But being not into fluid of versus people yeah, of get signal bigger you bringing to XXX Alzheimer's, bit essentially that space spinal lot in it you when that's about. antibody antibody addresses just that and of for we've So the of

it's than that concentrations substantially means lot where a that oligomer least it at tells are which compartment I I us through intuitively CSF, of a sense. the higher would in think So going that or think makes

in So talking terms you interstitial compartment in sample. antibody about in so directly you really of when that a excess you're can't excess, are bringing fluid antibody an

figure thing to tricky So it's a out.

the constantly But are we clear some to and look there's that's There target evidence there. sort case. the signal, you you were to plaques attached at -- these the thought signal oligomers the additional that regard on there's of get. plaque plaque target that would maybe had load analyses with bigger the was at no know do relationship that And engagement baseline We if real doing and data. more no engagement

a that are of oligomers these So than in compartment independent to appears different really be but it's spinal plaque, fluid.

spinal fluids team caveats the really the is now with working do oligomers fluid free assay with in action team at on that. is. look But So working the spinal an on compartment not the where is assay the all to an to

spinal less even in to with with. or It's lower. start antibody technically And peak they'll two difficult the oligomer concentration amolar are low fluid really really than then become

thing on a but So it's that. is working team technically to difficult do, the

briefly And just is is means thing experiment. amyloid it's positive that terms what and using that have in not to really will tau to of That because then, that other again sure, science play based in clinical on fluid. terms the of a people obviously patients. a how scan select I'm be spinal wonderful out Lilly or that PET did medicine which

range that right out have tau XX be of that that on the top for tau it of of essentially right eligible therapy will then be you and And people positive for positive screen one you but it. basically, means to in the

sure scientific So the a a I'm be that just that it's practically in you do from something clinic. not would standpoint. really interesting could

baseline see all varies to tau going that obviously that. if co we're at So and and of at look efficacy with

include made as not includes criteria. exclusion to decision the have it we an, But tau

specify to a we're of will certain positivity amyloid level and going make criteria, course We tau. of inclusion/exclusion an, but not

Tom Shrader

answers. thoughtful the for Thanks Great.

Operator

be please. Thank the next -- coming our question. you. one moment And next moment will for question One

Fitzgerald. Stavropoulos next from will Cantor of Our Pete coming question be

Your open. is line

Pete Stavropoulos

taking Thank for Matt and Hi you questions. Eric. our Dan,

So to data several now the that internally had and you've socialize externally. weeks

in the reasoning? in plausible Just some of females. mechanistic to, on thoughts ApoE ARIA your have Is chance, from possible curious homozygotes or hear lack mechanistic there only of observed is if a terms in evolved you. standpoint it reasons Thank by and

Eric Siemers

too. a question great Yeah. That's

is terms I that. Alzheimer's just off of for We'll I top more the I In that. common but occurring [indiscernible]. don't good females, females, see, bit honestly be still explanation disease have It mean could in don't a in have on answer a

a out a a morphology people that had suggest carriers is that came In homozygotes terms their one that's there just who that are ARIA week paper plaque the were different different of bit non-carriers people showed and than would that ApoE possibility who ApoEX which epitope than that a that maybe between of this have preprint was to actually targets ACUXXX an targeting the plaque ApoE. little relationship this antibodies

we'll need So thing to homozygotes see even size I study X the well thing further the ACUXXX. but mean of it a does but point if mechanism about a have observation, think differentiate I might other what discussions clearly is that it a to it for replicates, differentiation - lot the clear the of small if in we be terms is sample would replicate have and of first ACUXXX. this And Phase

Pete Stavropoulos

right. questions. taking you All for my Thank

Operator

of moment the the One next be from Judah Frommer question for will And Credit you. Thank coming question. Suisse. next

is line open. Your

Unidentified Analyst

for is This Nick question. for Judah. our Hey, guys. taking on Thanks

just with just right we that XXX with be but we So wondering, month just occurrence be I read-through holds with to that Thanks. see the and profile at what's looking safety post-infusion XXX? I bar from to were is the confirm ARIA you'd traction recently is to more know that seemingly differentiation about saw last wanted talking we lecanemab lecanemab lecanemab for reimbursement the that up. we're getting monitoring the just

Eric Siemers

of that the is I we that sort be rate on Nick. safety And that clearly benchmark I as think mean can better the for XXX ARIA do lecanemab the good think syndication. Yes. think – in a Thanks, profile for we or score.

our is that demonstrate in longer duration a that to intent So study.

Operator

our next question. And you. Thank

Yang is of America. of Bank question from Charlie coming next Our

line Your open. is

Dan O'Connell

Hey, Charlie.

Charlie Yang

for Hey, please. sorry the I two taking Yes. Thanks Jeff. for missed that question. questions is Charlie I think earlier. I have This

I favorability reason but think not kind make that Lilly somewhat That's sense the patients. donanemab I in data the can terms I that at for clarify show wondering as as you the the one. or understand as it shown terms well interesting, in preliminary with consistency specifying some tau inclusion probability that trial, lecanemab to I the the scientifically have in mean of more just post-hoc to regarding actually of it's what of to with I'm success? an efficacy the guess would improve also exclusion a lower quite given number First of of intermediate [ph] has

for up of way your discuss And think timing number I two of by the like long will run of just it cash seems when kind have the how end kind like the that can with trial around the of you by you'll rate the just the cash. cash that's given II – the end you end Phase

So some what's terms race partnership having in the – perhaps I of guess what's to or another the doing the readout? actual of prior sort kind outlook of

Dan O'Connell

Yes.

you want first the can Yes Charlie. Matt thanks, I if or Eric, I one – can to hit take So second. the

Eric Siemers

Yes, yes exactly.

So have and as in that than see in likely the using but inclusion, label donanemab which you'll up label what something an the we'll essentially of it's again, will challenge world a ends being terms track terms of criteria, I for yes, the exclusion tau think think think medicine. it work real in experiment. Again, that science great will a – clinical with making I that. of I in be more don't

study people doing And patient our beyond in so in mild that. with disease, so are or right? and either we MCI but what early is not our population are Alzheimer's dementia, Now these

score minimal can the is for So, instance. lowest XX, you have

INTERCEPT we used hybrid looking our this We've we're positivity. is model a also study, at amyloid actually of -- analyses ongoing and doing that in some is

based could on but pick be just able amyloid an so allow to PET you it on a it they a which cross threshold. positive, also wasn't So, may blatantly read, visual that not are people based to SUVr SUVr up actually scan who be

this having think help with us the tau population of PET step without scan. will take dial extra I to And in, a milder that so

future, to of next looking some may a Now we the just be future one of continue terms And don't in that's to time could to be II/III plasma III there But but tau the is yet that useful. trial, trial think we'll I or which clinical the these Phase obviously, and more when field track Phase registration is practice there that. assays trial, less as exists our have becomes if so make it a mirror today. a it in

And process so, was the Phase in thought trial. overall that the terms of the II/III design of

cash the for So, question.

Matt Zuga

Yes. Thanks.

So, Phase a Charlie on interim Phase following we study our II have at today. the should we runway to time, the anticipated way through enough stand-alone from positive III readouts our interim current it analyses. to we expand that not based assessment finish Phase II/III We study, a for have current believe,

that runway II by the through rates, be stand-alone a the on planning do a the cash subject initiation, our mentioned. we of have pace Phase course, Of timeline But current clinical affected generally, could qualifiers study enrollment site I et cetera. based to

terms partnering, III. we a of the to design In with Phase the think optionality expand of potential II/III using Phase the

the path is, earlier particularly would BLA As call terms Phase of to a from ACUXXX. of to III and mentioned us portion development on and I potentially of with continue potential the have working prospective we anticipate filing approval fastest in as partners, the the and potential engagement to

strategy, will to over year of itself. and next our things those the continue butter our are and evolve of So, part the kind of course of bread

Charlie Yang

much so Thanks Great.

Operator

like don't the to see any back more I questions Thank Q&A closing call And over concludes turn session. the management, for remarks. in to This you. I'd queue.

Alex Braun

Lisa. questions. are further if today available, have Thank company listening the Thanks, you Great. always everyone, in. for here you We at

Operator

call. you conference all joining. This concludes today's for Thank

disconnect. Everyone, now may great day. You a have

Acumen Pharmaceuticals (ABOS) 8 Aug 232023 Q2 Earnings call transcript