ABOS - Earnings call transcript Q4 2023 | Acumen Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to Acumen Pharmaceuticals Full Year 2023 Conference Call and Webcast. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Alex Braun, Head of Investor Relations. Please go ahead.

Alex Braun

Michelle. Thanks, welcome and conference year financial XX, and our to ended the XXXX. update business results to morning, call Acumen discuss December Good for the our today Executive Daniel me O'Connell, With Officer; are Dr. Chief and President Officer; our Doherty, Chief Jim Dr. Development Matt Eric Financial our Officer Siemers, Officer. Chief Business Zuga, Officer; Chief our Medical Chief and and

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

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

turn over Now the Dan. call I'll to

Daniel O'Connell

year today. to for joining landmark XXXX a morning, Good Thanks, and us thanks who's Alex. Acumen. was everyone

received nonproprietary at positive sabirnetug Phase delivered results and of July. which Our presented monoclonal early disease, name Alzheimer's ACUXXX, antibody last first its I exciting recently AAIC treatment the for

they Chief Officer. delighted Acumen this our Jim the many later to Jim have President You'll and team. years we of join serve about for More sabirnetug's CNS differentiated how profile experience drug Development call. as him Dr. Doherty we're and hear cornerstone and to on therapeutic in establishing as recently, these results more welcomed leadership brings development,

Acumen further sabirnetug believe highly of to patient therapeutic target for We Alzheimer's execution This engagement month, CSF or our focused and Portugal. abeta biomarker establish potential details Alzheimer's initiatives XXXX Phase entered Parkinson's a disease our population. Lisbon, I We oligomer a on we of strength. from the and the remain at study additional key best-in-class assay strategic ADPD treatment of on position presented INTERCEPT-AD International in about early as program substantial option the Conference and the from data

We from academic results Neurology will broad at for Denver American the in of INTERCEPT-AD practicing and of sabirnetug. neurologists. to And the will also this analyses April, present this introduce which group Academy development plan meeting the

in already at data. website haven't can taken our If presentations, results you sabirnetug I our the find entirety, a where you I Phase to their webcasts encourage you releases look detailing to and archived go

Phase and abeta oligomers. insoluble for important to distinct I For sabirnetug the in this in are high these sabirnetug and us, our neurons going it's anti-abeta monomers oligomers matter? Amyloid how synapses. abeta Why toxic plaques, the field. results they knew study of selectivity to difficult particular, significance in overstate and and broader does Unlike abeta into We position that possess ways,

would making oligomers provide to efficacy, may and in any substantial data and provide from protect with towards expectations as a INTERCEPT are existing an options. efficacy are of to this both, to track I'd sabirnetug safety next-generation that that indicating sabirnetug's Simultaneously, track effect. Phase additional results paths sabirnetug's we Eric. be the in of II a a exceeded patients, which initiate the mid-XXXX. call half our amount selectively compared study, see of we synapses launch way to patients like drug year. consequence on Overall, on first which with beneficial to ALTITUDE-AD, AD pleased target for of note we multiple with remains great is as progress differentiation or initiate to I'm also our especially therapeutic perspective. The to over I our the hand benefit And to approach Our that, to on abeta toxic study subcutaneous expected to Phase

Eric Siemers

the results received updates with design next treatment from X review into and then we our and far a were be in sabirnetug by the development I'll of year of to results data call feedback very biomarker The positioned scientific our the last throughout those the in second as our update to external we announced our and Dan, listening last year year, potentially a today. well study ALTITUDE-AD. those evaluated line community. year With Recall provide community to I that top subsequent progress recently Phase for now of on pleased fluid at with trial, XXXX. totality last deliver the AIC, INTERCEPT-AD and can the broader and of I results had brief only analyzed. thanks Phase community. I'm the are available half thus Thanks, on the become the the on July has Phase clinical Alzheimer's have differentiated we our achievements were

fluid helped to biomarker sabirnetug the relate results to of the We mechanism pharmacologic believe downstream its have activity.

July, Emax a was dose in seen in dose-dependent sabirnetug reduction in an measured engagement reported the amyloid PET was at by a CSF the highest of approaching first As multiple-ascending and found cohorts. increase plaque doses in in target

Alzheimer's amyloid multiple sabirnetug CSF, patients improvements which downstream X study, protect of synapsis of oligomers administrations only and of demonstrated X may were dose there the biomarkers X administrations effects synaptic sabirnetug's of drug. the ascending main after target neurotoxic pathologic disease. Remarkably, are tau clear suggesting hallmarks across just biomarkers in in of portion engagement and the additional after Importantly, on

clinical randomized, around been our to medical as package our even more Lisbon. results double-blind, has be ALTITUDE-AD next As a feedback Dan about enthusiastic INTERCEPT-AD ALTITUDE-AD. study, to from at caused us excitement returned recently data The conferences mentioned, our is designed efficacy, placebo-controlled our with MCI to intend safety beginning The positive. team participants in primary ADPD a study planned per very the measure. We dementia the XXX arm to tolerability the months of Alzheimer's or for with disease. participants approximately mild use to X-arm XXX iADRS outcome sabirnetug due total as of and XX evaluate at

for especially X-year of per PK/PD milligrams Phase our weeks. The Based will data led modeling study XX be to and from selection kilogram, Extensive the a the consideration every levels benefit on XX efficacy extension. planned include doses with these per to to will X may the dose kilogram INTERCEPT-AD, of milligrams the is and are terms dosed results both doses. ALTITUDE-AD clinical Both of I we these data, in see of open-label regard engagement safety differentiate they overall and risk to whether keen of ratio. target produce

this study study as a and study Importantly, providing is progresses. for designed updates we as and sabirnetug, the registration-eligible to look initiates further forward

our treatment results lead more have with our best-in-class to Phase I uniquely may short, abeta to a to allowed will move next for us In patients targeting oligomers Alzheimer's how disease. definitively study investigate that

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

James Doherty

I greater team the time, potential to differentiated I've warm At in a program excited next-generation targeting selectivity for prefer a everyone. for side at and X even oligomers abeta profile about sabirnetug been onboard clear thank months offer now. Abeta offer neurotoxic treatment. I've their grown testing including oligomers, efficacy more the welcome. that to may compared in for Acumen its the very Eric, the By ARIA. I nearly good other Thanks, Dan reduced oligomer morning, see amyloid a and entire therapies, heart, effects sabirnetug like And or these Alzheimer’s hypothesis. to AD for as potential species are the brain.

that potential Phase sabirnetug's indeed experienced intended show record I should the contracted we program to strong on target Alzheimer's that site in to there and this patients for and support advantageous it's ALTITUDE-AD be is patients with a readiness. to beneficial To a bind track value shareholders. to We our sabirnetug recruitment downstream The maximize and and approach provide trial efficiently AD its INTERCEPT-AD and CRO great us highly to trial, results incumbent for for have biomarkers. with believe strategically progress clinical improve can

with earlier, work profile convenience for product for Halozyme Phase I formulation planning bioavailability also volunteers a subcutaneous we a are that includes a a for believe we study a in mentioned productive option healthy caregivers, competitive to flexibility mid-XXXX. We sabirnetug and for Dan to and initiate of collaboration additional As stream. and subcutaneous have sabirnetug in offer patients

Conference Before Matt, XXXX moment to a I'd I the the observed the to like a call we to at weeks ago. few highlight take ADPD excitement turn over

better biomarkers precise sense joined and sabirnetug's diagnosis a from perception sabirnetug disease help entering clearly abeta is develop of have in will this development increasingly the effects era Having contributed to early Alzheimer's for believe fluid the can to a in the how more to clinical team's that oligomers biomarker will the and underscore on continue I therapeutics, new the We in after only treatable with of just We are perspective. of X disease. administrations the forward treatments. diagnostics recently clearly field even the the treatment INTERCEPT-AD data turn novel pride of that for Acumen, the biomarkers observed In AD downstream potential particular, AD. field move drug treatment targeting

Matt the discuss to financials. hand to And now I'll the call over

Matt Zuga

Thanks, Jim.

results our up provides on proceeds financial available in the public the well marketable to $XX XXXX HealthVentures The in of morning due securities As the press today. net from $XXX KX from XX-K a approximately file prior from debt sheet, to and ended million full $XX us million. deliver cash financing financial as part to We reminder, approximately with approximately strategic XXXX July resources million is offering against our objectives. we later we in the this are as which our of issued will we $XXX November year million our as of balance announced last release and year the increase in the with

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

related the from result This of million led in the to personnel R&D XXXX, year, materials, with in was expenses expenses $XX.X consulting. drug manufacturing million and primarily a related were the primarily increase costs, XXXX. $XX.X The were over prior costs costs to to increase approximately personnel. due XXXX. $XX.X G&A operations million over consulting of year to the in increased and prior loss

Our capabilities, we are strong have and experience reflection with positive XXXX clear elevated in Jim's a of insight. further drug our Phase I results which development

capitalized well We II our ALTITUDE-AD are upcoming execute to develop to Phase and subcutaneous formulation. a on study

delivering patients, sabirnetug forward shareholders. and for We to the the on caregivers providing opportunity us we of ahead updates as additional this committed of to year and are advance look benefit

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

Operator

[Operator first Neena question Bitritto-Garg comes from Instructions] DB. with The

Neena Bitritto-Garg

mentioned guess, you rationale analysis, anything then just based you for study share of doing that whether doing that about protocol know us So regulatory I thinking III recent interim how study. that analysis in expected in to a interim you order that adjustments may interim recently to And should you're the of consider start the the analysis walk wondering you off through, make you you're I for terms I of not would Can ALTITUDE-AD was in just feedback? about be ALTITUDE-AD can in -- the criteria an Phase some determine or great.

Daniel O'Connell

Tate, this is I'll quickly that. Dan. Maybe take

great So question.

to as interim in to towards provide us that protocol. on visibility the Phase really some study. not early change way be intended terms to decision the it analysis, They're make progress data III a of whether analysis these allow to In ALTITUDE-AD a will any

early these for -- just II the employed they're not space futility -- no not Phase the but minimize purposes expansion to between analyses. They're Phase in they're the the some and an will visibility they -- of not are effort analyses, potentially to So III. getting be -- longer white

Neena Bitritto-Garg

any consider That's donanemab changes based feedback then may to ALTITUDE-AD Adcomm? design making from Okay. helpful. And Got the it. guess planned the I off of you super that

Daniel O'Connell

Neena. Thanks,

measure exploring have design the some donanemab don't anticipate for serve -- The is Adcomm, the using continue in iADRS outcome overall barring do primary. X good certainly the and based associated A-priority a the ALTITUDE-AD development our Adcomm data primary use iADRS development I should any referencing, the to We the So of as we perhaps and field, at we'll the some set. Trailblazer venue as the XX expectations think unforeseen with interesting you're considerations with months we on our in as as Adcomm. an to for change changes make

Operator

with The question BTIG. next Shrader Thomas comes from

Unknown Analyst

This is for Tom. Sam on

ALTITUDE-AD the So study? option subcu of in for subcu, on therapy application open-label is are maintenance dose subcu your what dosing? immediate integrating a for part and extension the thoughts And

Daniel O'Connell

thanks of for the question. be to for the subcu that Sam, yet phase Phase I or determined So decided. is your the development And answer quick is beyond on it's think I next

a immediate inform done I strategy our Phase as be primary next in means executing you study in study focus future. a this the couple what to there might available or PK the getting So of as mentioned, a the dosing gate the for that II plans. prior volunteer focused I But for might is on be healthy on near-term, bioavailability as describing the I we're and Phase Phase to to really different options are us think greater Phase detail II the

Operator

The Paul next from comes Matisse question Stifel. with

James Condulis

a looking maybe see being you following win one about Maybe then James just up this how quickly quick on talk -- clear study I what to Phase the you're a on Paul. on is for just powered terms And the in guess, This on interim. of you can there? II. and again,

high a of share at about consist both those curious thinking the terms clinical may of level, data in that what just biomarkers of. you're of collection what curious a or Just scales of if you can actually sets? or Just kind

Daniel O'Connell

Eric, And to James. do take that Thanks, you one? want

Eric Siemers

Dan. Thanks, sure. Yes,

for as So typical study. mentioned, per pretty for XXX II XXX II That it's with Phase you a participants I ALTITUDE-AD for iADRS our study, power gives arm. Phase the

at that We'll really of the also we Phase program too. terms of most we should of variety biomarkers, our at develops. I a feel how which like question look study So in answer the in looked

see to X in so since it X biomarkers interesting [ actually months. doses response response really a months saw XX treatment, of already be ] after tau's will after And we just essentially

So to we're that. looking forward

terms thing. details just doesn't algorithm into that not In an I into of what to I going we're one that. get guess can that analyses, about goes interim it's the say include

good. algorithms the to a the trial if And that reduce one so white because -- mentioned, of is and again, of And of design Dan space tells space white don't do study is study have times, And is development utility the a is that II the will as redesigning and that, the drug III you cut programs in positive, studies. white between if of things that to the II down our Phase Phase Phase space. what we creates that a lot look on

algorithms. how that's we plan those to So use

Operator

from UBS. Bristow next The question Colin with comes

Unknown Analyst

This is King on for Colin.

earlier earlier formula. around the the centered question for following question was one quick subcu maintenance a more Just on study. the Since

thinking, So charts to subcu doses subcu do the with you lower reasonable out therapy, as for first. therapy, like think as for dose schedules initial the safety initial in pushbacks as you Eisai's dosing for some and upcoming bioavailable with regards study, to currently is test start dosing recent are and especially subcu what

Daniel O'Connell

Go ahead, please.

Eric Siemers

we to yet. all those are don't Yes. great I questions point. No, even questions think early really that and volunteer mean an I have answer all we data healthy don't this at our have

considered. to be So those all things are

that and interesting maybe switching the starting more -- then of maintenance talking off administration with starting subcu with broadly it's a about in as are IV I dose. think to field, people

just thinking about. of people something questions. down lot not we'll are need But actual thinking to that something that's data before start get that about. those So we It's we're to narrow on things just a

Unknown Analyst

question, Okay. And may. maybe quick if follow-up we a

recent include trontinemab. you update do some So in how from data most the evolving field of the the view Roche

Daniel O'Connell

take I that. Sure. can

trontinemab. data, We is I took view think which differentiated which a ADPD targeting the oligomers as shuttle encouraging. construct, is the that the gantenerumab from we mechanism trontinemab noted early a the but

the sabirnetug options. different field treatment And it feel a general, accommodate exploiting in support a as to targeted so in option the and that and very large and formats evidence committed to -- generating variety enough is product of of of oligomer we're much mechanism

So very it's interesting on looking focused staying and execution something we're for but at sabirnetug.

Operator

Meacham The next with question Geoff from of Bank America. comes

Unknown Analyst

has number symptoms, the publication symptoms. XX think beta that on to specifically of a studies? This of biomarkers think design bit you studies to amyloid found Jeff. of before signals maybe number kind A-beta earlier? of the up And that seen progress. delaying influenced years time enough prior wanted to Do broadly. appear for Jason reversal I I quite recent need of early little the sufficient is the the of little A-beta some the them? is you or that the regarding do on pops for some bit XX kind symptoms AD a clinical curious, Congratulations either of Or to or onset go your XX ratio a I'm may ask you that We've a feel more the a have of of for of

Eric Siemers

Yes.

Dan, take great So do question. one me to want you that

of to progress develop to of maybe XX years you the that were symptoms. that this field in time XX Alzheimer's are and one ongoing had the way and that that, point fact preclinical XX there has that in target have actually it people the is in disease. ongoing. understanding if the the have the all. even or going or There before last another, abeta called out, amyloid a any ways real yes, some been thought you do they field what's before any been had there to you years of period, the studies develop has So studies you of symptoms as And that And made you XX plaques at years last been because one

symptoms So have you far, studies you the of successful. other been Thus have those words, but yet. plaques, have any in don't none

But pathology. donanemab what's why seeing and stage is MCI like the reason Partly, is designs complicated. the dementia design or with either the drugs lecanemab so as have a to for to the is a well study mild back more aducanumab, really even Alzheimer's that why technical and and have you're need out. who people you think, don't that's challenge. more not are all potentially in longer much important, be there's lot I think preclinical I worked to much of some or that. way And for The study studies reasons that's means it's that signal a where that important go challenging reasons

feel I about signal apparently, of starting So are see that's fact broadly. is means really late And dementia. for a that field that MCI process. drugs insight really And Other the this mild the that's, the in to a what we there. plus are in think, we good too not population good

Unknown Analyst

maybe FDA released I this Interesting. quick draft if Alzheimer's may. a for guidance follow-up, The And earlier month. then

be? of indicators that takeaways is push for kind I several think length it the one might again, of regulators? of that And we potentially biomarkers using, your the here other the take of rather than waiting a to big that thinking maybe discussions are driver to with to meaningful and kind Phase if shorter to detect codified years really again need I'm translated change. again, the III And clinical a curious, shorten has studies ahead maybe

Eric Siemers

a Yes. language Having and talk to a have read read really the little for a shortening about between what guidance. did but these biomarkers, certainly some about It's they but draft in validated guidance to timelines hard there the validated of is on lines, lot times they draft mean. biomarker using like then based

to is things converting IV may antibody that that still a there's they worked So need comments out. it directing of and to to subcu. number then that taking those an be just It some were of be

on biomarkers. probably the that's most think a of straightforward case more I reliance the for

point, payers, for early we've to course, not considered this the biomarker alone to this of a get approval But try offered accelerated stage, because, reimburse using haven't to accelerated to sabirnetug least really really at approval. for at

have anticipate closely. design. in at changes don't to III I make continue information any be we'll think what So But we this to would enough would Phase point, we that our real very watch

Operator

The next Ghosh from Wainwright. H.C. with question comes Ananda

Ananda Ghosh

probability immunotherapy Are a the The thing iADRS anti-abeta as either ALTITUDE extent to what's a tau trials. where how CDR-SB associations, been which terms of is of can iADRS what were kind has you in on been lot reductions with XXX, second probably made biomarkers the success there CDR-SB first iADRS. much need rationale some question the done the is biomarkers study. you X choosing what advantages might impact at for to plaque behind in and of has seeing? over other And based some such tell change CDR-SB see to some XXX of are of correlations there of you And of the so of in these studies or other modeling-based as these have or least an over

Eric Siemers

that too. try can I Yes, to one, take

the As only it Boxes. a interesting what the mean that real the did iADRS they called iADRS far of combination may of to what that's most CDR that have It's boxes, idea recent scale that But didn't sort things of functional and ADAS-Cog presented measures a CDR the measures one scale. from And from they is as endorse recent they a the guidance measures cognitive that's draft scale longer draft and where in the they then public called ADCS-ADL. utility. that was of measures versus in guidance composite draft boxes, the a Sum of previous meetings, actually Sum mention did of of functional the use as And guidance this is. cognitive CDR say the they've was the Sum of no out that the at in

of think trailblazer of in that. that happy [indiscernible] it's iADRS. to the They assume our their terms the very that's we were studies, So use I would see that actually positive primary.

good a scales. in really that that's kind from think of clarification I yes, -- of FDA terms those So

that at of correlations is get is going time for we long a clinical target of been what's if that have benefit, to opinion you think rid saying that is plaque have you threshold. really Acumen plaque, And you're get certain basically to a actually this below terms In consensus and a becoming reduction now something between to it. I plaque

XX, based say, And on the be [indiscernible] to data to get or XX. goal that seems so existing below you most want

need your to what is plaque. But our you want not do. target target if -- So if again, is plaque, that's you to

oligomer. target is Our

with be plan. differentiated interesting But on our what will our of really not have the plaque. to it effects development that's see mechanism, construct we So

Operator

the further show like would call at no remarks. Braun over Alex turn now back to questions I to for this closing I time.

Alex Braun

Michelle, today. taking thanks time the for and Thanks, in everyone to for tune

available the always are at company. We

questions, touch and follow-up any great For in have day. please a be

Operator

concludes This participation. your Thank today's for you conference call.

now disconnect. may You

Acumen Pharmaceuticals (ABOS) 26 Mar 242023 Q4 Earnings call transcript