Acumen Pharmaceuticals (ABOS) 27 Mar 232022 Q4 Earnings call transcript

Thank you for standing by. Welcome to Acumen Pharmaceuticals Full Year 2022 Conference Call and Webcast. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Alex Braun, Head of Investor Relations. Please go ahead.

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

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

Dan. the call turn I'll to Now over

first Acumen target to was morning, Alzheimer's and the oligomers. by soluble joining you, development marked antibody pivotal and Thank significant for year us developed tested selectively today. discovered you, beta of patients for advancing ACUXXX, progress that XXXX monoclonal clinical in was a the Alex. everyone, amyloid Good thank

and production experienced of disease. I the the RAE members we to a Track in we on INTERCEPT-AD our level engagement results will results safety are in and to quarter. may plan line support to in pharmacokinetic the added including the team X II information target ACUXXX far, as received talented early then oligomer oligomer, mg/kg amend in and this provide work by that I information course XX mechanism to A-beta FDA, February, the believe us more observed announced cohort clinical ACUXXX, to to dose mechanism of safety prior will ACUXXX cases that shortly. Thus target the with disclosed X every data PK weeks. we important antibody product meaningful trial, X indicated in Eric an trials date, development data supports PK weeks and study. this which third enrollment The the proof proof important preliminary Phase such Alzheimer's in of completion we XX the in provide provide reduce of for of to just INTERCEPT-AD Fast anticipated dose-ranging establishing cohort in report observed for us study. in cohort encouraged Based enrollment. antibody dose CSF year, were are we of blinded concentrations the on of that in and preliminary at X, in engagement every the protocol for the CMC protocol to completed our to mg/kg Phase opted X, top last up the Over year, to the dose of our at cohort which reported blinded in time, to greater scale the In our and of to selected against want briefly fight safety, designation of anticipation upcoming thesis that the speak completion February detail appropriate from levels, guide profile sets excess data And comment considering ACUXXX concentrations. A-beta differentiated our We

we ahead, preparing in Phase third for II/III results successful Looking activities actively from the quarter. I study anticipation our Phase are of in

FDA design an the study II from We decision meeting end will a design to interim to II/III fourth expand to discuss II of Phase an be a III held study. request our of to a quarter that Phase incorporates with the in Phase the Phase size the study,

to remain well front, CMC of requirements plan. manufacturing development current drug On supply positioned scale sufficient to we have the our to meet

play clinical results safe negative targeting the plaque. Most in A-beta targeting that targeting complete to as plaque-targeting development that In the how generated in our of and graduate the beta a disease the evidence reinforce near driven acknowledge achieved have Phase antibody produce study it antibody can monomer and landscape clinical potential addition, at the for past we oligomers monomers a for protofibril hypothesis a be on of antibodies plans. removal part only stages that not treatment can role ACUXXX formulation support the We soluble may the in benefit to negative explore species means subcutaneous beneficial based Clarity targeting viable Alzheimer's fall in beta the AD continue of [indiscernible] options in renewed patients. Furthermore, to overall amyloid be a for advance assessing meaningfully as progress a and for would such study. On interest protofibrils the new is to plaque-targeting with of for of options lecanemab treatment positive field. data Alzheimer's when over I intervening contribute like disease. AX various significant the pathology such results The for the our antibody, may Because in recently, for XXXX intend final results aggregated product the a gantenerumab, change options note, made lecanemab species, a development a year. of beta and to even a has efficacy meaningful I earlier

field the amyloid both sets, also future of seeing which is continues data and are in clinical and advancement PET these could alternatives effects rapidly of in AD develop set imaging. from beyond that biomarkers, diverse imaging Aside predictive to a offer fluid

Given target inform we of a top to and you data of line companies data in the our approaches. At size many set look are the clarity these provided upcoming field we the these we have advances the from and additional believe disease the and we by third in quarter, different from to INTERCEPT-AD learnings data sharing ACUXXX therapy to engagement use a forward importance additional will with Acumen, our as Alzheimer's the recognize this end, burden, the perspective. to developing a strive with approach forward potential to disease-modifying to informative patient dose-ranging look data be safety population. To encouraged

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

Dan, morning, Sweden, ADP Thanks, the where this meeting to happening Gothenburg, good everyone, and today week. from that's I arrived attend

have quarter, most dedication the and advancing to line of results minutes their the February. site This as enrollment INTERCEPT-AD them personnel, results. CRO completed to and some delighted and to I'd like importantly, ACUXXX. With our of our by true hard by trial, I Phase expectations would expected thank is few in work our and the I context partners. now team to we in take study the support testament ongoing shown like investigators, are third patients, top a for around for understanding our We the their to those provide of potential families a our the announced in

Alzheimer's Our The study safety administered PK and with The disease. trial primary with Phase endpoints I is focused are objectives study PK. enrolled randomized the for of intravenously. trial controlled placebo establish are engagement safety to tolerability, evaluate early first-in-humans, a SAD/MAD target and on and XX patients ACUXXX, evaluate

other seen we RAE aligned As far monoclonal expectation. amyloid amendment with the encouraged support this we and observed less the at expected first of safety, of seen antibodies asymptomatic remain we doses. that we the X preliminary We than the preclinical beta safety disclosure oligomers. their trial. Based that quarter as in February, will with RAE that date, to highest in in targeting our were blinded January some ACUXXX, of cases, profile cases data, And XX that in soluble of protocol blinded on had announced as had support

monomers. levels concentration the XX mg/kg species are program which soluble lecanemab We cases next know than -- were to mg/kg levels generally every than central of case, line for data provide such this X Oligomer sufficient We barrier evidence in also a a as dose showed of a reported that is the effect. Keep other which in antibodies, several support oligomers. central dose donanemab. The that less pursued ACUXXX compared of above to RAE note the XX cohort our every pharmacology CSF data concentrations the ACUXXX. phase viable be higher reported aducanumab, a and that preliminary including PK in is from preliminary we weeks by in for CSF blood-brain substantially this do very low Cohort be thinking. of mind well ongoing that hours that [indiscernible], X crosses PK to of X at dose could ACUXXX XX mg/kg A-beta as disclosed is test is X other If doses considerably our

engagement. to target Turning

detecting is designed oligomers complex assay ACUXXX down target the As know, CSF. engagement Simply administration threshold. you to A-beta the satisfy the complex will after target many the in of for our to of measure engagement

similar to mice complex. to materials Acumen both a studies, A-beta brains specificity conceptually at complexes trial in for and for measure thus transgenic specificity an look methodology the the ACUXXX was administration CSF and after assays nonclinical In from ACUXXX oligomers Merck the using increase for INTERCEPT-AD is proprietary these oligomer immunoassay. that developing using able ACUXXX

Phase include Importantly, and our to has we database if cognitive MRI flow are spin built with optimized. Exploratory study prior lock assay to the labeling effects performing trends measures test signs into arterial is for be of cerebral I increased. to understand sensitivity early of our our ensure blood will testing that scans computerized this

a result significant are trials the a clinical effects. potential in be study ACUXXX. detection would analyses a on important unlikely Depending exploratory in subsequent these of are treatment using results, suggest central our measures in employed duration, and Phase While signal signal may small this pharmacodynamic these statistically to I with short

would include clinical to cognitive testing to Committee upcoming decision II a and toward Data by a diligently to our been Turning of Phase evaluations measures, the a Phase algorithm study. study, Monitoring working an computerized that enable scale clinical the III to biomarkers Phase develop go-no-go team study II/III has

I'll allow are Phase III. And We method with call II Phase finalize go-no-go a to to Matt. confident the algorithm to that, rigorous decision that will provide over we a turn expand the from to

Good Eric. everyone. morning, you, Thank

this later are last approximately were afternoon. We XXXX ended financial morning from $XX.X press our through million we over that to in operations million cash the available primarily marketable XXXX and in and year to the The million over on approximately the that R&D the results be year-end expenses headcount. in expenses ongoing the of in we release this cash of $XX.X G&A continue and INTERCEPT-AD in were complete prior the the due This to increase trial, securities in XXXX. filed runway with increased XXXX. XX-K activity million primarily XXXX XXXX. led the increased year, to sheet, was Our loss prior increase result $XX.X $XXX will expect issued in and a balance

open has XX, Silicon XXXX, our we to over execute operating our well we Bank, in for to and our moved as had line in will for and reporting look and resourced INTERCEPT-AD capital years. with all of Q&A. cash the approximately accounts March for ACUXXX, to Operator? few We institution. In top patients which our in value remain Regarding $X.X million our shareholders. And as call disciplined to there we we data that, next can to XXXX against another third priorities advance the financially of strategic program forward to conclusion, deliver remain exposure use of quarter been clinical Valley the

Paul Stifel. Matteis Instructions] with question [Operator comes First from

size the study? And at how is a the have then this difference your analysis recommend one where planning, typical or sample just the interim stop to adjustments blinded you're group On I to follow-up. data, interim looks similar that

simple Thanks, going was explanation, a there's Paul. to on comment Yes, Eric I invite to that. think. I I mean

Yes. Right.

I that's futility sample well, times at I analyses clear so be should size. In the you're [indiscernible] that's done data. actually adjust measures. sample the algorithm emphasize thing on lot discussed, words, other of we in the and adjust and a we're right, One analysis that look based trial. And I quite are everyone that. interim to complex So things itself a a have is look first we about the mean -- purely But usually, more a of like bit is developing than not the we'll as the just thing sort statistical done just sizes. interim should to that's clinical at the analysis,

And completed at and also those develop like would will it so the to it doesn't fulfill to be algorithm, be so the study then successful, a as DMB, some a to the up Phase things. this results look the look and study. but little algorithm speak, III to see the if Phase the scaled II of be is again, we'll and size computerized then give study. If at we drug will of ADAS-Cog. DMB at And will the to effect we'll study it algorithm testing this, look some a in MRI cognitive surprising biomarkers. there, And the our We

a at study the next complete study. a minimum, as we'll II So Phase

little then you've enthusiasm sorry, go a bit And -- ahead. more about talked Okay. Dan,

was Well, I that's not and just X comment. obvious, path -- for the to is want intended Paul, -- to potential just of if the registration I say the going product to that to make so fastest hypothetically, X, design a really course, be

this response mean lower half these that on engagement might dose? thinking in you you've how scenarios And I the that this a Like more seeing, if are assay? dose guys then confidence in No, on you're Is clear target XX take anything you see what a the dose. of don't that's you about talked about clear. second guess, mg/kg forward year? based Does

Thanks, Paul. Yes,

I So comment. I'll mean, just

in study, I we in really the based the the on and February some made PK amendment amendment think the RA protocol the observations -- including case.

the of roll a until position So that in the I modify X it continue out to when cohort decision don't obvious to to sort the think not quarter. made dose level, we're we third think just I that information dose X. the do us might overall couple XX the concept for at required original XX to versus time, cohort of a drug was which dose viable weeks, to be that every given mgs of in terms at became the

So I that gives XX thesis in and are mg/kg intact is much particular, for level X. encouraged that that's we're of the X, the kind modification of really for more and us with ACUXXX the very sort confident ongoing the Cohort overall between cohort a think mid-dose information mg/kg in XX

with question comes The next BTIG. Shrader from Tom

almost the question had you If anyways. more to say, it's same

question So a removal. about how the There's little of I have controversy world still plaque a of bit about some is. important it

a might important confusion, trial to kind sense kind plaque of given the that we much but that think your how into business. all ignoring on or it's how is own that is But going you of unknown look? be call have about it Are do issue? to important where it your be an it trial interim look? removal is, with with how think going that interim an FDA they about would okay the in And I what's that is

I maybe can try that. So

for And then that accelerated words, predict plaque approval. likely other an to from standpoint to reduction, approval. to led the FDA "reasonably an reduction that plaque was FDA in In considered the clinical a be effect." accelerated So

And all of and scaling an decision-making to Now that any III rid of in Phase of Dan approval. I things clear you're analysis then regulatory of clear, again, have I have even II in essentially as has graduate efficacy. plaque, one demonstrated anticipation to target Phase accelerated really more to become I It's to of that think terms before. sort that, studies for approval clinical think you going But get NeuroMab we're it our any is that very in case, a mentioned, the if was it it this this study study. internal well. up And our or doing not interim of think a

there piece So interim doing regulatory isn't it. to as a we're really analysis the

would current anticipate but -- practice. expect not in conventional the And move I study to just would the again, think we see and to it that doing are just standard -- kind a and as of Tom, doing that dramatically, it, we

with from Colin comes next Bristow Our UBS. question

[indiscernible] is This Colin. for

X have we if may do. follow-up and So questions a we

cohort is last our in MRI first not the for yet have received MAD. noted scan. The in they X question patients you In correspondence,

Just general. you the so, those And update? And now? by wondering more if here. any question Do dose if given plaque-targeted you then faster frequently could kinetics have general a safety turnover ones, there's more they oligomer-targeted antibody received is a provide core second think than correlation to

question. your Thanks for

on as the one, that continues protocol. think Eric back to and noted We and per Cohort first we've February in in conjunction mentioned, protocol I RA I just proceed as the mentioned the with amendment. cases X Eric disclosed

provided cases haven't information other and so we RA any of in So terms forth.

I would it on Eric oligomer with mean Tin's that the Eric, antibody. of comment I turn question ] I I aspect care think in think would terms -- to to frequency maybe yes, question. respect dosing of [ you to maybe

Yes.

it's to antibody straightforward have you in our And than that and we're case, antibody maybe in little CSF preliminary X, antibody that so it's So do we necessarily a there words, it's at data in that that that excess. fluid. In want question. really in Cohort we that you with a is obviously binds oligomers. in XX other dependent going time an for an on a the in and antibody response fluid have bit not once starts even show more the In targets the were that I asking actually was for more up really was to really think it's plaque, spinal any one of spinal show would to the mg/kg, excess. the so exciting the it reasons so microglia, not you're which PK is is what PK plaque, why And interesting that inflammatory antibody see data, found given since you plaque, us

And little so the is situation different. a bit

I our show in we're right. thing again, excess. But to in case, antibody important that You're think think is the I

Sorry, really yes. helpful.

We [indiscernible] mentioned of have earlier the on a follow-up question, like AX. prepared remarks Dan kind has in question, also, which what

targeting, primarily So we understood touch to sorry, it solanezumab not does monomer but any plug. it some is -- primarily has though capacity oligomers,

were will And to we any maybe completely our yourselves. hear best is are following efficacy, greatly some needed the for failure appreciated. of treatment some still there us that provide concerns could to are you curious be So if clearance solanezumab color

a Well, of Dan, since do solanezumab. you want I have that with familiarity me ahead bit take go and to

for consistent really First resolve, press there need all, data. of the was for that of over a to mild actually AX was milligrams disease were favored surprising interesting and the What is we'll been differences, course, weeks. Well, when was X at at placebo a the in terms and Alzheimer's there's X,XXX of milligrams just actually, no people drug, trends statistical see the of though releases me were weeks, all even solanezumab bit dose very and drug. given to trends with that favoring X every XXX every

with way So you data has the to anywhere. reduction target the and to you also NeuroMab plaque get really have it taught dose solanezumab always that to rid and bapineuzumab of is certainly all doesn't get a bit of the think the have understand bit all I mystery, a we'll get and of plaque, to really see you want little why thesis if field back a to going been has that didn't that higher you again, of see our that. But

approach that bit think a then as you we let's monomers target don't this plaque well, little reduction. could saying, I So of need and

up probably successful. not think would end that I being

targeting mean clarify, your understanding. I are do pure any of -- aware And oligomer you properties Eric, to just almost have you to antibodies to it's a my monomer binding solanezumab, for --

specific of somebody conditions. vitro binding remarkably publications my consistent all and quite -- you artificial now the and little find those always been so And been of studies is for always Well, that in this that. they're has can really to shows solanezumab actually that's that data a typically, monomers. sort of I'm where are aware kind But

Really, principally monomers. with and XXX has target much developed oligomers to been have interactions

with Suisse. Frommer Next Crédit from question Judah comes

question Just thinking amendment to story preliminary potential you compare you you then. and the I change when have on impact getting how RAR might acceptable key XXX, commercial not we this need the MRI to does How to of in had are got levels payers prior? And for between profile protocol that. in of that that profile? probably with comes monitoring might reimbursement some discussions anything back that around you else sort way might the and a have the needed thought about that you lecanemab any or now guess And

question. Yes, thanks, Good Judah.

in of -- So terms a that. into I lot think wrapped

antibody I rate may relative -- oligomer-targeting think of of XXX continue safety profile offer profile, to does as plaque-targeting that have in terms antibodies attractive such XX.X%. the we safety an a [indiscernible] believe to and

safety that's that use So sort internally. a of benchmark we

terms to In dose that formulation. but dropping may that the XX becomes subcutaneous a a amenable mg/kg be of level, more

standpoint. was cohort that to a So what with consideration actually most from really in early February part do the programmatic of what contemplated we made set as sense the like

will So prospects We've important point that at subcutaneous format that we've we'll information of does help earlier cohort call, couple different for at moving mentioned a provide was on of PK I modified X options -- the -- XXX inform and dose some to as and that. as a that into looked see. the

We that always study, the routine anticipated other do we've think MRI for haven't had purposes. general as se. any safety payer I next envision scans for -- interactions and development we've per

instructive that what would to as study commercially. more required be much I is be likely to think

overall what's rates. So I definitively in we in and RAR enough really from the required say in overall. This a Phase INTERCEPT-AD have the won't to what's terms of a just required from this exposure -- study the product is study safety

Instructions] to no the now to like turn would I this at closing remarks. conference back questions further time. for [Operator show I Alex

us for everyone, Thanks, Michelle. today. joining Thanks,

follow-up additional As always, any have you available for if we're questions.

company, out at the and reach great us please So have to a Monday.

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

disconnect. now may You