Acumen Pharmaceuticals (ABOS) 15 Nov 222022 Q3 Earnings call transcript

Good day. Thank you for standing by. Welcome to the Acumen Pharmaceuticals, Q3 2022 Conference Call and Webcast. At this time, all participants are in a listen-only mode. After the speakers' presentation, there'll be a question-and-answer session [Operator Instructions] Please be advised that today's conference is being recorded. to Investor conference Relations. like Braun, to now of Head would hand over the Alex I Please ahead. go

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

listeners results or future undertake Q&A. no or for accompanying the actual in presentation we'll factors call developments. information issued the new could open Securities to forward-looking the accompanying filed note implied encourage the that to release annual the find Before as press we prepared risk of we we today. this that presentation our go outlook for Investors press slide this section and and conference Please information remarks, call, We related statements. our the statements to may results with from from afternoon, materially statements those Acumen differ our Federal Please of result begin, call laws, the today's expressed important on we'll discuss those that slide most obligation to to revise plans. make and website during After two quarterly our These afternoon update to in forward-looking within our including release provided and issued statements. presentation, the reports subject cause and business cause the differ statements in the financial see to this risks a SEC could materially described are uncertainties of recent of our concerning or or expected that or results meaning actual the forward-looking

Now, to the I'll call over Dan. turn

you and call for Alex. joining today. you, thank Good our afternoon Thank

in lecanemab whole. improved The due role plans the which Fast-Track Aβ designation the the recent recent disease. for results, progress provide highlights, INTERCEPT-AD design and increased reinforce FDA, critical will may to The for start note both on optimism several trial discussing ACUXXX and a then the ongoing by the that renewed include our ACUXXX for context and as clinical also third quarter and trial, momentum highlights in anticipated the of amid play some field like fronts from comes species enrollment that and the Acumen. our operational was for characterized positive I'd to trial I'll publication our Alzheimer's INTERCEPT-AD ACUXXX. soluble today Siemers by and Dr. Alzheimer's comments business in developments on field development

the updates Turning clinical discovered trial antibody XX Enrollment enter ongoing our soluble from at to Aβ developed target clinic. X oligomer monoclonal ACUXXX, to selectively now the the to is sites active and in INTERCEPT-AD of Phase first US.

As originally the previously trial slightly last year slower initial enrollment projected. of experienced stages XXXX, early than patient noted we the during in

in patient has the four recruitment enrollment last and accelerated However, months, considerably.

visits various partner closely timely third-party the also imaging at with protocol, include CRO our conducted to and sites scheduling the per We ensure are clinical of study working which sites.

the X/X clinical are to to completed expectations that activities been for are which targeting we quarter a We of the we of subsequent of the have topline XXXX Based pertinent first are trial, moving quickly very year. to the trial that note, half results the enrollment of the encouraged provide an pleased in the should I want trial, status, on or are I In reporting update underway. anticipation in some and also profile safety momentum with second our ahead holiday completion aligns Phase current is accelerating season. enrollment observed with in of ACUXXX. date on the

of phase in chronic in-life and On has the first XXXX. is the the report toxicity toxology expected of successfully front, study final quarter GLP the completed study been the

led by ensure is and clinical study planned in [ph], support X/X and drug controls readiness who joined to this manufacturing chemistry Leanne of Our as Shank team the CMC diligently Head for Phase working of ACUXXX. June,

development completed manufacturing produced have of new drug We process our X/X Phase production drug substance first our substance and lot.

development also to have manufacturing we drug Based drug lyophilized requirements meet completed We to this plan. sufficient the of the scale our development formulation our supply have progress, well-positioned of on and product. of current are

hypothesis and effect should we our As AC-XXX. confirmed non-proprietary our part the of is safety for influence name the consistent favorably antibody, efforts ACUXXX which have application for function a reduced of IgGX subclass of the ACUXXX, subclass outcomes that as with CMC consensus this for

development to for Though options readying pay that X and next the the dosing of were products do on development to focused we subcutaneous plans. a the opportunities of evaluate assess for we close product, in our for continue generated advancing patient formulations formulation of potential of antibody other in landscape on with for and attention our product Alzheimer's observed Phase capabilities subcutaneous study, our part acutely will as field. development the of information the plan Dependent we continuously development our fit phase ACUXXX INTERCEPT-AD expertise. We

the valuable With Officer. more the our as creation appreciate greater in We Chief biotechnology be our On Dr. and a addition over call Eric? a also I'll value future. being team, final the continue quarter, during and hand spanned that, career at decades committed opportunities, pipeline in Legal are legal adding of both companies senior Derek the Meisner to to leadership is could to firms, has Siemers. expand such leadership X the and highly to note, the we capital team. investment deployment company but evaluating than Derik's expansion Eric third to senior path he selective and a

Thanks everyone. and good Dan afternoon

this that high this for end, of disease-modifying are population FDA We are of clinical need and Fast-Track Journal in patient Prevention trial on designing our This criteria therapies. of planned based the recently an ACUXXX such an ACUXXX, potential the the committed To for Alzheimer's plan in to ACUXXX treatment advancing X a clinical disease. development design we early Alzheimer's or designation and INTERCEPT-AD in Phase granted We article to ACUXXX. Disease the additional for clinical clinical delighted outlines to ongoing were that advancements recent for with efficient X/X disease. a trial methods recently Alzheimer's the underscores utility the innovative unmet of Phase published research in

tolerability, article, acceptable engagement advancing the we at As doses trial parameters, and X a in Phase be and and the Phase tolerability. will for from a safety to criteria based pharmacokinetic target on have safety that X/X detail

therapeutic various for analysis have design innovative the trial, the we patients. could and X this AD more Phase with with finalized do for Pending sample sample then several not whether meet as be the to in to cognitive with clinical may could us Phase the of study, the development an measures the X correlated if interim patient begin typical and load. analysis to the Phase X/X based power it anticipate for trial, patients potentially INTERCEPT-AD in interim the target a increase of to the statistical determine a X/X trial. would allow Phase design oligomers of regulators, the registration expanded, Alzheimer's adaptive discussions rapidly we a fine size planned the plan interim the disease X/X serve would While promising trial the Considering cerebrospinal in design blood on early Phase analysis a This example, positive has study Phase typical trial trial. evaluate biomarkers, of is X as and

prior in at Aβ take readout between results results trial at to oligomers, than a targeting study making more targeted Looking was It soluble include and the The GRADUATE the a X our gantenerumab at protofibrils, target species, and less symptoms lowering in role plaques soluble look lecanemab, include which to look relationship oligomers, progress in species designed reportedly of are more XX to also are may species, fact today is known as deposit plaque gantenerumab the the Alzheimer's disease amyloid field to supports broadly, also what and to were insoluble began announced lowering amyloid driven against are the that amount is approach further the more field CLARITY-AD the upcoming amyloid progression I'll Aβ than which for as we now disease discuss We lecanemab The negative complete ACUXXX, the positive the fight soluble fibrils expected, relationship as The Alzheimer's with for exist role major disease. recent to species. Aβ play that disease. was similar plaques, plaque of XX to underscore for a Aβ years which Alzheimer's and program, CTAD these the detail. of the between and view plaque onset important importance Meeting. protofibrils may a complex assessment describing antibody monomers, renewed rather plaques. minute the cognitive deposited sole Phase them that so slowing which and and monoclonal The is of has similarities soluble. pathology of is a these a well-established. of ACUXXX

deposit course Following with of of This of are plaques named the begins neurofibrillary data degeneration of not begins cell toxic. development occurrence the suggest in the and with inevitable other death patients and the disease. appearance that tangles [Indiscernible] eventual plaques synaptic temporal occur with themselves to brains Alzheimer's

lecanemab, of believe are long-term years soluble targeted the activity Phase soluble indicate since their trial that as of forms includes success a by Aβ of we we both benefit significant source believe that similar Considering ACUXXX. can for of well recent ACUXXX. announcement the of potentiation, X and brain improves disrupt one ACUXXX the from the amyloid and function. Many toxic, species inhibited by electro-physiologic a However, lecanemab normal these in are the probability data lecanemab, soluble known which as species plaques own targeted together, protofibrils statistically species, as target that oligomers be they research Aβ cells these

does a ex-vivo little gantenerumab lecanemab brain abetamab patients that based compared consistent better suggests highlights rate a imaging. lower or lead as to gantenerumab studies lowering profile. plaque, This to though the be targeted on of studies have on other plaque and reduction directly monoclonal disease. with abetamabs gantenerumab protofibrils somewhat rate human atopies than oligomers finding that antibodies rate with a to of target PET announced with of plaque using based the and RAE safety appears donanemab. Importantly, to would less species Alzheimer's no targeting directly load may animal lower for such directly ACUXXX even soluble that ARIA and plaque, further than antibodies XX% tissue or exhibited challenge donanemab compared safety for plaques Aβ plaque it today rather ARIA lower Aβ

minimal that of and occur with investment call hopeful are clinic. for turn therapies equal less the we with in or no The And that, Matt. reasons, Alzheimer's development foreseeable be continue an or ARIA efficacy these will For over to the the disease. future will in ACUXXX ARIA opportunity I'll to with greater

Good Eric. you, afternoon, Thank everyone.

year And increase on with expect to in the quarter available balance and approximately sheet million this second Q&A. clinical This increase the ongoing quarter. capital strategic conclusion, for in in execute we can of XX-Q R&D cash we marketable over with us in activity for XXXX. $XX.X and the trial. value primarily year Our securities cash to $X.X remain quarter our a are data our program prior our shareholders. to XXXX result led multiple year-to-date look September that, at was in million million in prior priorities. were half achieve to loss period, quarter the Based through clinical disciplined milestones. in The our today. $XXX well-financed were over to the with results the from the provides topline and increased million headcount. XXth, the which increased third against we a our and the last current press the the deliver $X.X strong G&A filed plan, complete we as the Operator? INTERCEPT-AD and runway operating primarily in INTERCEPT-AD to use release the our expenses call We third and patients of financial due the operations financial in In ACUXXX to open issued approximately third XXXX remain with development for ended forward position, reporting afternoon we period advance we on quarter. the to we'll expenses

Instructions] come first [Operator Paul And from Certainly. Stifel. Matteis of our question will

Your line is open.

playing of Hi, the -- dynamics of of speak you to just mentioned on is in it for be that's and for into you're looks this how ARIA baked with the any later Phase at sort kind Thanks kind half be signals was specifically, wondering everything Maybe clinical what maybe great if could second causing on clarify would question. the see but of taking in [ph] readout think if James seeing in XXXX? good. if blinded anything kind I sites, But specific much. I'd instances just if question, more and Paul. you the our or they're Thanks exact then enrollment I is X to you so just understand great here. kind And the to is of understand great? what kind be of of would second a that you're expanding all, specific in to any delay delay,

those coming early in session. James, question. of Q&A We through Thanks, your the both anticipating were for

on table. them putting for thanks the So,

of of kind and legacy the from think where are early updated kind terms XXXX. enrollment XXXX, In for we or aspects guidance maybe late of with the I of XXXX

of study. momentum have sort results, we considerably, of within six-month the the in quarter. enrollment where up essentially So, shifted the in to and terms half we've back And topline first based the in why to and guided of guide picked of traditionally elected year on we've window are completion to a the has is which

encouraged study of -- consistent and review terms are we has we of to have safety can't than that are, we elaborate as In very I profile than are stated, standard original today, as to clinical aspects I for has on go suggested ACUXXX the with progressed of the measures. observed encouraged more but But on safety I what review data the with further kind of thesis as at won't various date. say where that, as what think blinded I've kind of safety, we

Great. Thanks.

Shrader BTIG. Tom next from Our question will of come

open. line is Your

their interim you terms the Good something follow How think of How measure sort Aβ afternoon. oligomers Thanks curious easy you more think those antibodies. for in in Just elaborate you being clinical that taking with assays it trial that setting? time? And had useful Is to those? a time? Or an it a in from prime question are directly is a could are could I is use question. on the asset? of something look? with complexes for ready where you is

question. is one. for assay under the development. It's Well, pertinent yes, thanks a very That

down already, oligomers We that the what than but the as have their are the prototype that is sensitivity is I lovely measure probably symptom reason increased. to found is to being oligomer And reason XXX. And oligomer directly, antibody are the know, in a to very should rather concentrations mention trying the measure think trying to we I you for the that, range.

our do is just is oligomers. and study to to want take is we becomes XXX it by it concentration And that the begin then to trying technically antibody you're engagement and in do definition, bound feasible. gets to really, lower, what the target But so just oligomer with low not when show

So concentration up actually dosing. go with the will assay working we're that on. that that's obviously And

interim question per Now, formal lines But there's interim, to looks at get Phase the of X analysis for se, we study to no about do safety our analysis. interim data there's routinely. no

the for mentioned. details all will I the out Now, we're working And that. do might still interim we Phase into go X/X, analysis as an what of

X/X, yet. will of X the of we haven't this but Phase X/X that need don't finalized on part target as our the really the out design engagement interim that the I study we'll of again, think I probably know study. Phase come Phase

in very flux? I prior to design life. trial? [ph] a you as Just your your good people If idea? on next a counter-pathology it's are thoughts the in Where Is you to still of going question to from recruitment? a follow-up much using that a one be with can Okay. think you're Do big

Yes, Right. very it's interesting question. a

as but part a sort that programs you better, have using are of And much. the -- not to criteria. and too a [Indiscernible] it's have inclusion/exclusion know, the think counter-pathology I as of little

defensible. think from a very that's standpoint, scientific I

I'm would positive much that not not of the has way, out, too mean, just a standpoint, especially to you talent from idea I positive sure amyloid how be and think for And right tau. the clinical in have practice. then practical it the by that to I for little. be amount play

I standpoint, for practice. think that from understand practical a quite in could scientifically, difficult I be rationale But it. the

Got the it. detail. Thanks for

from come Our UBS. Bristow next Colin question will with

open, Colin. is line Your

Colin. for Yang taking for question. our [ph] is on This Thanks

We two have questions.

competitors? opening your question with co-creative the you. it So the is CTAD second do clinically example, you of you is the think the first is presentation, to slowing, that at specifically one level for Thank And for are looking what for that attention relevant?

Thanks.

ahead, -- So I think Eric. go

Well, yes.

So to presentations positive are to the of was seeing data, more we're one we negative. seen to in consecutive on looking think results, terms and those understand CTAD I both to press the really those and need We've meeting, But on you Obviously, gantenerumab, referred the days, think which we're studies. I for of see the releases to forward looking presentations. was presentations. forward

there's as efforts question, this is disease more XX% the actually to quite question a of being far is been think, broad number meaningful, Alzheimer's progression consensus -- As meaningful. understand efforts slowing become better, by your or field this clinically second and an clinically the for a including important by there's I about Association. relatively has Generally, that's

threshold. on it consensus that that So would number, lecanemab XX% based cross for

I the you point time you very having progression obvious and for is in cure the single in some huge the this field three and understand field a By to have I I the it will The thing get is XX%. this XX%, the that so think another think is XX% expectation at meaningful, slow shows that then effect, might on XX%. people generally, next very, one clinically think, meaningful But got to an And and disease but with don't start used now. us. you process drug effect a trying two I can't some lecanemab, think that's start personally drugs to in that, lot be place, with that's cure if disease drug or of combination lecanemab or for drug by what clinical right other threshold the a out is expects The going think that anyone to therapy disease. the

helpful. very you Thank

Judah Suisse. Our next question Credit of from Frommer comes

is Your open. line

Thanks the Yeah. taking for Hi. questions.

just, follow-up from from those Is that or to assets? late-stage Dan, issues call it's whether anything largely publicly information commentary available enrollment First, you'd else on the against around late-stage Is XXXX. trials COVID? other out, there competing

Judah. Thanks, Yeah.

I terms COVID the standing activation of it's in certainly and issues -- course in legacy study the think getting patients access that the of mediated were the and stuff in pandemic. to -- that up XXXX site

sense a I whether we've of at to our get sites with think of se. we're necessarily not to per sites, -- best tried our competing the studies understanding, other

We study in a are patients. X Phase doing

of out has formats. ask multiple game of taken, lot that So momentum the study. year current proposition rolled And I of a we of messaging getting the value ground the over in sort the the lot refined the impacted course we enrolled, I the of this really think steps of that in the patients we've and think that kind a

progress, team we've to of half I explore updating recruitment. the other shift don't the year, a back and year we and progress over -- towards as course things of or half some additions current the avenues the this right second can little lots certainly, we've result to the but with is obviously the the gotten of of made think that we're attribute year of know I So

progress So elected the play of now, are again, operational quarter with in which we've first the why elements is kind and to to guide really we're right the encouraged that enrollment.

XXX elaborate Officer. follow-up around your conjunction obviously, it just you or I and of would more a think would Understood. it could with Anything is And commentary be to on, then regarding Chief development, kind is on development the that around thoughts assets work business in prepared remarks you new that? what Legal hired in than business

Yeah.

script color I'd did up the to has in want business I Judah, comment that, a pipeline strategy. as of been question. it's great think expansion it I some for add our picking business the So mean we there. part to Thanks always make

the XXX, and asset. perceive a kind noted, things as success and on expansion think of criteria success for higher more forward as priorities Eric looking think that for heels probability I are the aligned of supplemental XXX -- that are lecanemab to we additive or of and with that I pipeline complementary, the what going

think have that, of we have requirements be time things a be we and specified we investors. for and are shareholders, reasonable by have and are to look potential appreciated that think at looking we're do deployment beyond as going capital, that I specified don't pretty frame. judicious capital and So milestones I valued would also near-term

Great. Thank you.

Charlie Bank [Operator line America. of Instructions] from is open. next your of Our question will Yang come And Charlie,

This Hi. for on Charlie is Jeff.

maybe guess CTAD your question of correlate a of X more you ☺of to more boxes your you see with which by said there extrapolate help to Phase cognitive more of are sum that from or gaining Thank results? can second the you. the specifically can like is kind other the is all my kind regarding what that confidence regarding beta of we assumption first CDRs what to I how like traditional test, computerized will the of with gantenerumab presentation data are somewhat about measurement assets? and lecanemab So data, from And kind and that any publication can use cognition

tau plasma thanks CTAD important a compounds, be I and will think, into and spinal as both for yes, lot will fluid, there presentation, like biomarker dive be or gantenerumab. a actually interested, lot of the are things Well, question. There's there. as for effects far to phosphor that lecanemab, Yes, that

early on clinical months, at separation things the of one and fairly six drug least to release, according placebo important seeing the very that press is at and about which I measures, between our the remarkable. based lecanemab, is press release, even think were they

and take you with kind at the we're therapy. release, course the which expect of close again, time over press disease-modifying graphs the going in look -- time effect, but grow seen to to the the the of So a effect

So we'll looking for be carefully that.

So in those they X/X. Phase studies, terms the those and guide there's to of -- are just lot look design will our at I think a in us of

other CDR, how its tests computerized As will in to the with will measuring little measures CDR. battery up question your regarding are the actually computerized there and our three relationship or those Cogstate study, those The sample that you as Cogstate you far were the six we measures. with just of we're the where battery. Cogstate different be more line know, and a other. we're all measures, to cognitive three are measures. we Even CDR X our these small battery, functional each attempt as -- the items, have taken doing than may bit say are see a be are This That's obviously, doing Phase it size, but first of

signal picking sum actually, And especially certain subjectivity there. with done, of be there should So be testing start reason too. again, than X we to in the amount small Phase which for think Phase out to But give one study X the may chance would boxes, the study a have a of a a is up less dissecting front it computerized us have CDR the to better is variability little it. does putting if in of

you. Thank

Just follow-up. a quick

is initiation, sort going for late Or timing has frame X to to there time potential XXXX either to initiate? Phase roughly the the trial that is early some still for delay be XXXX of XXXX? or Regarding --

Yes.

to beyond have Track that that Track We have did around we be meets we receive to Fast use just of Charlie, study we large are unmet from it end X/X them a notion to going merits think, our as the is XXX interaction FDA, well the which as kind Phase will that our set possible. as guided as obviously I think be is disclosed the But to discussion. that review So previously there in certainly recently the early Phase I an some FDA And X/X of data -- to the I year of study time estimates, design. certainly we will need internally but in part stated XXXX. the a don't regulatory team. on our document, think We launch do a as We'll guide the our with INTERCEPT-AD with it's X notion And Fast from is XXXX best event. based start the expeditiously an early the that I looking need. principally as, Phase associated the Phase and that, think with in reaffirms is our X/X of engagement, type potentially can discuss goal the plans think briefing designation objective

Great. Thank you.

Great.

it for think I that's Q&A

further I’m showing question. no

a us good much you for company. right. for at Okay. That's night. All interest. if contact it you so questions, And Have Thank your Q&A. to should have any please the hesitate don't

conference participating. Thank for you today's call. concludes This

disconnect. may You now