Acumen Pharmaceuticals (ABOS) 13 Nov 232023 Q3 Earnings call transcript

Good day, ladies and gentlemen. Thank you for standing by. Welcome to Acumen Pharma Third Quarter 2023 Conference Call and Webcast.

[Operator Instructions] Please note that today's conference is being recorded.

I will now hand the conference over to your speaker host, Alex Braun, Head of Investor Relations. ahead. go Please

today Good Officer; call Olivia. 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 September 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

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

the remarks, After open we'll Q&A. for prepared our call

call I'll turn the now Dan. So to over

development. and into advancing the disease recognize of our differentiation via the Throughout treatment is us oligomers on monoclonal this efficacy selectivity antibody the increased high And clinical to next thanks, additional Alzheimer's importance We and amyloid may convenience morning, November, safety believe everyone, under-reviewed for ACUXXX, Alex. Thanks, approved and beta joining toxic antibodies. patients for with and living as early the of and focused today. disease. third team and improved for caregivers that lead options phase our to Alzheimer's for to treatment of quarter we ACUXXX's Good clinical compared

end, have and of deep from to our team. We and share positive biomarkers expertise recent updates the ACUXXX. to study, development Alzheimer's a Today, announced this operational and regulatory, regarding our by financing the of interaction we strategic I supported partnership development subcutaneous progress our made have significant FDA form the newly to Phase pursue CSF

be Phase will top-line the data CSF corresponding July their Starting biomarker near future. and in data team with INTERCEPT-AD I we an opportunity past International or data biomarker the from available results biomarker fluid Conference at yet our the this Alzheimer's had plasma biomarker analyze disclosed Association now to the our data, when not had are trial. AAIC, received

trial A-beta for Today, to data the presented were positive pharmacology downstream for the in and on PET I'm ACUXXX. effects addition previously amyloid cohorts share XX/XX that multiple ACUXXX INTERCEPT-AD reinforce observed total in the dose neurogranin engagement pleased and results target drug ratio. ascending further in CSF Consistent tau, to the Phospho-tauXXX, for biomarkers

X and particularly significant notable, as concentrations. cohorts, multiple in was Statistically level correlation with the well dose administrations any as not ascending of with kilogram per neurogranin ACUXXX neurogranin CSF target MAD effects between expected. effects are was at dose These of XX improvement entirely in milligrams seen engagement significant change movement reductions since biomarker the only in

I results through oligomer biomarker dive This detail will is with presented seen more and Phase received of for to is highly of I was have Alzheimer's the such we the as that to CTAD, shortly. the walk target Disease Eric tied the our corresponding compelling plaque Overall, community. data our medical our have downstream effects. pleased Phase deeper CSF effects be movement we design fact reduction, at INTERCEPT-AD supportive pharmacological study Clinical and very you the we of continue a amyloid antibodies guide or Phase by also insights and such the in biomarker A-beta October, the The very that trial target brain into to data Trials helped engagement. quality our the Medium engagement, CSF which well generated in now, II our in

target, target per doses showed IV In brain. were milligrams at kilogram near are data in modeling of X toxic per that direct and presentation I XX The weeks. these forward our on the at based taking both and basis our maximal and Importantly, selected of Phase Phase arms engagement at saturate XX CTAD, we as X intended treatment versus I administered part modeling, every A-beta II. milligrams the the in the other we of extensive oligomers ACUXXX, we'll data doses PK/PD kilogram, are of oligomers words, adequately of our Phase announced placebo These A-beta both on we confidence subsequent have doses effect. PK/PD

XX the may kilogram sufficient II in oligomer anticipate per efficacy target observed these level dose kilogram a index Phase kilogram per plaque the replicate think ratio. the of will dose engagement, milligrams achieve benefit rate or differentiate both terms of about and XX-milligram we lower will risk therapeutic be are may overall whether in study they Phase presumably levels reduction we cohort. see than and and but to the As we XX-milligram dose I, dose and keen clear, dosing extend produce To with strategy, per of possibly the ARIA-E clinical the

end update. We participants Phase of are it mild regulatory discuss we with dementia XXX, indicated in up cognitive next to of arm, double-blind, with were meeting The the to safety the ALTITUDE-AD. our planning participants principle designed study which is an per XXX with met study agency study, impairment study efficacy, a clinical in ACUXXX, FDA tolerability ACUXXX we placebo-controlled, AD. or the to total a design. to due as of the mild clinical X-arm Recently, II evaluate randomized, calling for aligned our and to that with Turning XXX

size to possibility which as ALTITUDE-AD of study of a an with study in is our expanding analysis Phase duration a The the the the potential incorporates with XXXX. and initiate study, approval. BLA inform a believe will Phase first from to the II we route filing commencing an III stand-alone interim study the II most XX-month plan to adaptive expeditious half treatment of Phase a We design

potential a timing from of to to as And interims not avoid interims be study, and these and FDA analyses and disclosed As from protect futility registration will the the not data reminder, bias. study's are integrity a guidance alignment with in publicly. the

dosing like of We our update this provide to I'd recognize of and of viability for on Now mode the patients attractiveness administration assess of convenience offer caregivers. to ACUXXX. an to additional and efforts the flexibility subcutaneous

evaluated X we months, delivery support have doses to last to the XX the exploring Over clinical are several we technologies our studies. in

about subcutaneous to our and PK excited Halozyme. drug very with compare validated global in ACUXXX signed agreement Using I enhanced a plan IV commercially are of form licensing the collaboration to form the delivery Phase of study Halozyme's recently to we We mid-XXXX. initiate technology,

believe product patients. ACUXXX to dosage X-week options a there we may profile our be broaden for ACUXXX, which a commercialized alongside of subcutaneous potentially treatment competitive form IV is of on ultimately dose Based potential modeling, for commercial every

flexibility. facility up a provides announced $XX And KX with a also health that finance secured we Matt we operational company. I'll care-focused Today, for to how with million additional let credit more us funding you have on specialty HealthVentures, tell this

at the back look has a Taking one XXXX, transformational thus year been a for Acumen. far

enabled to line clinical of supported of today. on results encouraging Phase demonstrate our for phase mechanism CSF proof which us from received the feedback positive data share next I the top-line by ACUXXX, speak. we the convincing operationalizing we further as FDA are of development, Our biomarker We

subcutaneous differentiated development option the a pursuit with profile to best-in-class And partnership our its choice ACUXXX provides Alzheimer's the the to potential greater of for development financing product early talented to Halozyme ACXXX's of future support support show focus in working subcutaneous solidify Our treatment. convenience. as and capital potential extends of the and option a team, patient additional of

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

and Thanks, Dan, good morning, everyone.

very our biomarker our with Phase we you update, CSF I regarding changes in to been INTERCEPT-AD study. data pleased productive the last to quarterly today since measured share have have have I'm and We

p-tauXXX, presentation If see can and of administrations you turn cohorts, today a on X webcast. earnings in website levels dose XX/XX to neurogranin the is our ratio. tau, effect you only posted X in In ascending and Slide the on the This dose-dependent CSF multiple in X trend the slide, of to total of first drug an drug. after the ACUXXX, observed indicating A-beta

pharmacology as in are supportive I we So of target highly Phase ACUXXX's engagement downstream changes observing the is and that study. our fact determined

neuronal of cognitive function, shown to nominally synaptic group has compared the and placebo glutamatergic a to that protein a of weeks enhancement a statistically ACUXXX linked is activity be the X.XXX. and neurogranin been Neurogranin dose modulate improvement kilogram plasticity in significant may per showed as synaptic to in every milligrams X XX and with p-value

between target action consistent These mechanism neurogranin data across downstream doses. also with of provide was There and are evidence the and target neurogranin. all effects also ACUXXX A-beta a beyond and significant of ACUXXX, engagement of oligomer of on pharmacological target correlation engagement engagement in change

may change versus XX decrease with target of it directionally further cognitive changes mechanism kilogram per was ACUXXX's p-tauXXX. is cohort, trend efficacy, established encouraging dose milligrams the multiple correlation nominally Turning lead with similar supports to p-tau's CSF p-tauXXX relationship INTERCEPT-AD in a We ascending of seen was given that saw a to clinical the for and dose because p-tauXXX This seen engagement. neurogranin, significant in decline. to

significantly correlations change biological observed X as a Researchers have p-tau, between change CSF and in biomarker ACUXXX. in our in Slide the further biomarkers which confidence correlated between X, that provides the neurogranin observations suggests with field Remarkably, found shown was p-tauXXX. in link with in neurogranin we and the these

that X, Slide to in by of were target load correlations A-beta determined to amyloid more PET. shown binding then and changes to related p-tauXXX oligomers, in is ACUXXX plaque as in engagement, As between closely decreases neurogranin

While support ACUXXX mediates that these analyses plaque reduction, than pharmacology A-beta concept downstream oligomers, its binding to potential not the benefits. conclusive, and clinical rather

with shown Slide in see X, We biomarker And change every as X. treatment. Neuropentraxin did we to on an effect would ACUXXX not not expect

relatively at near to by this community, biomarkers to plasma data study also symposium that new like about share medical CTAD in that being analyzed, more biomarker. mentioned. as will to well received be understand required some in highlight was that presentation of the we expect are Dan our I'd be note the and the future. Please process of Additional able to

oligomers, The important main is ACUXXX engages for Phase I oligomers, XX-milligram active would to would we that highlight hypothesis dose dose, our we toxic expect presentation from our II novel of oligomer in A the A-beta. from greater primary would conclusion dose, our maximal reach its I that the target target particular, brain. points and trial takeaway load our kilogram of expect addition, in study but in the Phase also as to intended derived kilogram per our target supported assays. At to target, pharmacologically and points based species couple presentation the data. selection the being in XX-milligram we would fully we from per most observed our interrogate have the nearly the our engagement from Phase engagement A-beta lower the confidence on At is oligomers plaque expect saturate based the on I even engagement A-beta to of A-beta

as lower our to robust arms choose Phase XX be The We to a would dose. per reduced decline. able milligrams that line kilogram ARIA-E dose I X been is kilogram Phase and active using compared expect could results, both of because XX milligrams cognitive II per study the level potentially have efficacious of that we bottom

reduction the plaque important takeaway INTERCEPT-AD. the cohorts dose ascending of multiple in presentation our is from Another CTAD consistency of

small without decline per which had For X.X test decline patients the increase kilogram essentially a in Centiloids, the MAD single PET, treatment X XX-milligram had on retest a in patient of is amyloid of X cohort, noise. a Centiloids

patients X Centiloids. of X cohort, a decline kilogram in per had milligrams XX the For

reduction the treatment on a that people of with consistency milligrams For load these due cohort, in decline in ACUXXX. X treatment kilogram The X all conclusion XX is per plaque aligns weeks results every with Centiloids to had values. the

encouraging the to of in of the been summary In clinical reiterate Phase working study our has for ALTITUDE-AD team XXXX. diligently this prepare won't summary, interaction II our initiation of quarter. Dan's I first half our FDA

for So are their to promise the Alzheimer's I a executing the on oligomer theory and families. for patients will ACUXXX therapeutic the option committed of emphasize that best-in-class hypothesis, A-beta to we be potential and

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

Thank Good morning, you, Eric. everyone.

today. XX-Q a this release and in our available XXXX financial the close that As reminder, our file third morning issued after we in will results press quarter are we the

As $XXX.X marketable securities approximately of September balance and sheet. cash XX, on million we had in the

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

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

to review Acumen's provides of was we installments capital which as as subcutaneous million. both up the from the ACUXXX, An KX. senior million closing, facility additional available, purposes. agreement financing which HealthVentures value general $XX be for for request, in discretionary I'm upon an $XX Upon as to $XX subject up loan development funded. This and well shareholders, secured dosage and enhancing the corporate facility pursue KX approval Today, for funded patients pleased a view may to of to tranche of form also with additional to announce million of credit $XX is of million

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

[Operator Shrader Tom coming our first with of the from BTIG. Instructions] And line question

a data. Congratulations biomarker on good was It the change.

which Eric, was changes. good your really it we wondering for you us logic guess I about, going talked A-beta go. it's for XX/XX would can, up? thinkers, walk I I through it we sure think weren't if slow way

much the are that then would least have you could thinking very those maybe a a at And questions. certainly at dose are you safe? robust tau my for a almost get of while, third about where lower with readout, So you lower be sense some doses if PD

questions. Great Yes.

brain X it's a reason, in they're concentration in far XX and the it's thought increased XX/XX brain. A-beta fact yes, because to whatever spinal with that's confusing. a ratio, But are of sort [ of up of in Alzheimer's A-beta fluid, even tied to patients the And the maybe little the as though made ] As shifts up and plaques equilibrium is XX complicated, A-beta little disease. for be decreased the A-beta that obviously in of

So in Alzheimer's, low. when XX you're your is A-beta abnormal

if normal means to it goes non-Alzheimer's take use if works the the So have your a ratio you towards A-beta XX/XX ratio. it But state. people XX/XX XX, and returning and better that you're you up,

So But going think bad we XX tend of A-beta a to a is thing. being up thing. fluid, really in good spinal

it as So really positive at we result. looked a

kilogram minimally to a should based cut milligrams yes, down With have effective ARIA per to We of, target dose. requirement carefully on X XX dose we find from group, those could dose doses escalation We explore do doses. you we for standpoint, just administrations the And outlined -- engagement those assay. were rate. chose as regulatory built after And the regard the tau, no really protocol a need on into drug. do the lower to possibility our which results the we fairly there's raise a impressive even

per So XX doses actually first then the go and that will X be kilogram, to get people XX. they milligrams

yes, it's doses, we So, look really doses clinical thought to efficacy. certainly be could it eventually, scientifically interesting at we would pick that -- wanted have lower X to but

Pete of with Stavropoulos from line next our question coming And the Cantor Fitzgerald.

Eric, of for tau p-tau clinical and so there versus sub nature. have that was levels, of had donanemab question and lecanemab, at benefit analysis subgroups one age, patients certain example, that I Matt great Dan, for baseline a with others, things group is, greater

incorporate criteria ALTITUDE? data? for learnings these these you for are how you inclusion/exclusion And thinking any the of So will about

Yes.

Another great question.

Lilly people So from actually with were but I presentations. the that interesting better they focused actually it a actually tau, And standpoint of had think the of very program, amounts those the on who drug. tau did less moderate people with out turns

disease were all gets people, earlier who in can it the that more. So benefit to idea this back

do thought that noticed study. our things discussion who quite But with their have trial And people, were people of of we so keep seeing in some in initially, study. decided have this of read a scans amyloid presentations, those in upcoming there's their Centiloid was you shouldn't presentation actually levels. because terms PET of after those think to we've plaque that that And one the study load very we our low on included going So about a include maybe may visual based low. is in we've our those in people I we're our bit

getting I be really So on study was those based early of we already set essentially, we'll results, the up Phase some way that know our people. the

-- the design about bit. think day, to them the at the quite was it to don't that fascinating, decided study. need we we change So the have our we But of of were actually data a end

showed in correlation between, or let's reduction right. And levels changes changes those the with A-beta All levels plaque the for today, any you of Centiloids say, of biomarkers biomarkers and that or any all in plaque was changes? there

engagement Well, and between with were target plaque changes. those biomarker Yes. correlations the greater correlations the the than biomarker reduction in changes

So conclusive, consistent that think way the again, related it's -- binding are related biomarker efficacy, reduction. our changes to the not to But plaque more than turned absolutely we data in very that's out. A-beta hypothesis the that's to case, this these the with directionally it's oligomers

Our Matteis from Paul with next question of Stifel. coming the line

for This Paul. is on Catherine

And say On then the do prompt expanding at might you you in the expect move II/III, And interested be study? can on taking the would when interim? you into what what look to the interim? Phase in a else anything

the we're Phase algorithms the and we will But details to II/III as the to get to recently minutes, a study we a mentioned, opportunity, that III. had I we II on decision the position elements design. as scale interaction and today. into the an think inform the in we don't go Phase So with maybe going up comment FDA on running, and But I think some information. to from share get meeting not have additional Phase favorable

of question from the line next UBS. our coming Bristow And with Colin

I'm one learnings then Maybe there? do at for first had approach and subcu did that progress. XXX? And you will take II? what terms the were Eric. sort question, on curious, the data Congrats any key like secondly, to to of I'm just but of a Eric, long CTAD, you in that your saw administrative Leqembi of that to what how -- the you enroll surprises from going then this you think it's more subcu sort And how of Phase change curious,

Okay. Well, with then afterwards let we'll the the me subcu and Dan. question take talk about other first,

But the was ARIA-E was with that researchers pretty driven this lot terms anyway, a hypothesis that was subcu, that was than what interesting Cmax about of by there in of really was prevalent AUC. rather

and And that And you'd you think it so in to have formulation, so that AUC. was subcu to be related experiment pretty case. a less with the this out was X definitive. in just it more Cmax not driving so to Cmax But and be science was have have definitive lower turned case, ARIA-E, would the unusual I ARIA. just It's not

question. And an to answer we got so that

field, be for it going useful safety standpoint, can formulation actually, of -- I that benefit. more other to that and be people there's means sort matter for think not sort of well, it in what thing, from still a thing. prefer, of our having people in having a that convenience convenience, is But probably a subcu terms patient and of the people

and but want to something we at. definitive So got still -- look that standpoint, is we answer subcu to from question that a

talk So timelines. to I'll about Dan turn it over to

Sure.

on we the as operationalizing study, of are and mentioned, mode the focused execution. In terms in of ALTITUDE-AD we

investigators others of interacting at there site in strong that terms in and the In study. interest had we with CTAD the field, in and participating was a feedback the demand

participating So for good is particularly interest moment a with time we're respect in in that. to optimistic in of and that we're the XXX, research,

are we've the specific of a I timelines that stand some of will for timelines, enrollment on mean get There just provide to but to enrollment, detail, inform months terms outcomes. in more we'll be got and over next In have and running. specifically additional too when happy XX up developments to we early where series we terms it's sites say. are what visibility our of

follow-up Fitzgerald. a I And from from Cantor we Pete see question have Stavropoulos

I characteristics do ARIA had very to another, of with Eric, at for an baseline Again, It guess, donanemab. presentation by analysis -- interesting and CTAD.

implement you're want how if Phase just that to I that to data Phase sort for you're of and implement take hear -- your to II? Just your any your factors on those of going for going II,

about presented know, the you didn't status. And a risk factors ones our that Well, we ARIA. APOEX of yes, of talked ARIA. APOEX homozygotes, And is one have of for things that we've one we've the lot interesting big any as cases is in X, before

standpoint, that found it's -- more whether determine in II/III study APOEX and findings were factor not risk ARIA-E. these from will carrier surprising So think interesting, It's good. some it's that I clearly for Phase status but is of upcoming a our

obviously would clinic tested APOE people risk some be status that begin factor the recommendations really because carrier now there's beneficial treatment. you their before that be in for Eliminating

not or for APOEX Some would you at either were some drugs approval. not -- clinicians, homozygote being initiate are that if looked the approved of would an

a would think, really as major a I liability having that be really clinically, not So benefit.

Okay.

like And the factors, anti-hypertensives? some of other

The...

the me I'm bit those really definitive least those would would think a Yes, study. change They're sort want we there's data. I interesting. take results that of to head that we I for design little replicated there before sorry. X in of a the at seriously. our don't of yes. interpret kind That's see of anything thing It's those It's enough difficult, to scratcher.

call turn now closing showing Alex remarks. questions. to back I'm Braun the further any will And for over no I

for today. present a We lot Great. information. did Thanks, joining us everyone, of

we any for you Have are company have great available a So day. questions, at you. if the follow-up

conference gentlemen, for and our participation. Thank conclude that you does Ladies today. for your

now You may disconnect.