Acumen Pharmaceuticals (ABOS) 12 Nov 242024 Q3 Earnings call transcript

Hello, and welcome to Acumen Pharmaceuticals Q3 2024 Conference Call and Webcast. [Operator Instructions] I would now like to hand the conference over to Alex Braun.

You may begin.

Thanks, [ Tawanda ]. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended September 30, 2024. Dan Chief CEO; Business are our Matt today and CFO Officer. me O'Connell, and our Zuga, With Dan and Matt we'll open have some prepared call questions. remarks, for the and then

Doherty, we Joining Q&A Siemers, our Officer; also our Officer. Eric President Medical have and for Dr. and session, Dr. the Chief Development Chief Jim

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

the Dan. turn I'll to that, with over So call

today. morning, everyone, and us Good Thanks, thanks for Alex. joining

XX expected, our beta and our execution clinical next-generation for completement We has faster efforts sites due in the of from sabirnetug, robust ALTITUDE-AD evaluate the action, sabirnetug's I XXXX. enrollment continue progress the ALTITUDE-AD, the to believe of North early Phase across to the currently active third with half to in now A than was first of for anticipate characteristics we Phase II America, is roughly as enrollment from in investigators study The enthusiasm along of we interest by bolstered options mild stemming we to mechanism due site and as the efficacy our dementia U.K. XXX antibody a contributed all team across Alzheimer's Furthermore, have progressed sabirnetug. impairment establish and of collaborations ALTITUDE done has than or factors X rate designed top data. has promising disease. one therapeutic safety clinical treatment to trial mild focused Alzheimer's our to well more the potential enrolling patients treatment effective sabirnetug in and regions. These and quarter innovative of reinforce oligomer-targeted the cognitive of enrollment with and our EU. Enrollment with sites

next steps have PK hand, continued anticipate to the progress We have to we we for results Phase first the and XXXX. Once also best in study line quarter formulate study I subcutaneous positioned this be our top will of the results sabirnetug of available be will sabirnetug. in developing subcutaneous for

meeting that is field to capitalize key share takeaways this a both underpin see on at anti-A-beta the how era. moving exciting is fronts, treatments advancing on and particularly couple AD. the field clinical was Moving research to of in momentum. meeting our with clear the Alzheimer's the the time for I We CTAD in on a at ahead new to Madrid, and that into And strong position it disease-modifying a Acumen want

biomarkers in fundamentally happening impact First, our settings. now. research the blood-based enable right This are to frequent is were including biomarkers innovations during new development and Blood-based topic in meeting, clinical a multiple both presentations drug own. going

participant use the people eligible procedures a which we trial. to approach. Furthermore, At assay in our for from a more data enrichment the is screen Phase resulting patients results to XXX Our this approach are unnecessary scans lumbar ALTITUDE-AD process our function not participants pTau screening. criteria amyloid approach that proportion by Phase reduces did continue on has efficient higher in potential among this trial, inclusion presentation about of contributed selection to our the I reduced PET screening reported focused of are compared enrollment. phospho-tau compared Thus which to PET who amyloid rapid not I meet we in PET the enrichment study, INTERCEPT-AD ongoing screening the as Phase it clinical study XX% research that using CTAD, XXX to far validated plasma II in or incidence and negative the CSF-based as scans use who amyloid

for first and them and available Second, patients as real-world in future. to the clinical opinion for support serve the under will all the presented the Leqembi currently leaders key populations. are In for we R&D October, from the believe U.S. hosted the Day the Acumen the team feasibility space. protocols highlighting from and grow delivery ultimately and not anti-A-beta of continue of Though of of of Japan, teams. Further, cornerstone making management the treatments Alzheimer foreseeable and researchers in with we we have acknowledged were members treatment the of diverse limitations a products and the the patients, reports right treatment virtual adoption adoption and use right geographies marketed of AD

had you is the If available I encourage you website. view to webcast, replay a haven't the that to watch our on chance

Phase results for sabirnetug. the a I provides sabirnetug's and A-beta rationale of toxic The the event positive Phase dive deep plans scientific are clinical targeting action supporting into II mechanism clinical oligomers

the Additionally, shifting organization. to

Dr. regulatory with week, announced XX CNS a of over Head and Officer Amy of to Schacterle brings in disorders. therapeutic on assurance we Acumen as and Amy Quality. the development focus of last quality Chief years experience appointment Just Regulatory affairs,

at aligned ahead Given of led who her thank also strategy development, Janice development key are regulatory in we the our and focused her our on goal refined driving look of retiring instrumental approach onboard end in her advancing regulatory a sabirnetug efficient a sabirnetug. I'd diligent the our product the treatment and risk and of that, recent the We profile. as in in manner. been in data II into strong a to wish to Matt sabirnetug's the Dr. for our the data year. development the with clinical I'll amidst with Janice strategy. call to affairs our and expertise experience new infrastructure, field, refine Acumen, And further for development clinical scientific forward strategic Amy's confirm our are Hitchcock, deep developments work product of providing efforts regulatory we thrilled along the we global retirement. At over of like and The we sabirnetug building data. strategy financials. to disease have I as has updates with promise benefit understanding turn the towards we with as to in And Phase a best progress next-generation as overseeing clinic. Alzheimer's to option

Dan. you, Thank

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

last the prior the year was were to million approximately expect we marketable that runway into half quarter. XX, in expenses to in The the on $XX.X R&D securities had the and September XXXX. ALTITUDE-AD sheet continue first roughly of balance in in over spending million cash the third $XXX and net of cash As due trial. G&A primarily the loss increased of to quarter, $XX.X in quarter. the $X from to period led the loss the expenses support the million prior million were to million operations a of flat year. This $XX.X a to same increase and

was quarter accruals. ongoing million $XX I'm in of burn million and cash very million, with in interest of in net the the the in noncash which impact pleased income, expense includes approximately expense compensation Our quarter. the stock impact third our execution net $X.X $X.X

formulation We advance have II to sabirnetug. necessary and resources subcutaneous Phase our of study support the a

the opportunities patients, We are to and with alike. And call caregivers the to shareholders for can Operator? capitalizing dedicated that, benefit we Q&A. open ahead on

with line comes [Operator from the of question Paul Matteis Stifel. Our Instructions]

Mark for on It's Paul.

X study. on had subcutaneous Just the

do for next expect plan that steps, how studies? color? potentially So to what data Any more there? into we kind And can of you then future incorporate

Yes. Thanks, Mark.

the IV. administered and of and So in is bioavailability we're evaluating I with subcutaneous volunteers, Phase healthy study sabirnetug the pharmacokinetics

So a principally, help want inform then to that format. advancing bioavailability PK steps what subcu we take next with will precise study it's a

steps it's a think I be until to next see prespecify will bit we the little data. those what early for us

[Operator Instructions] comes next BTIG. Shrader from question Our the of with line Tom

can it Or seems release you an better we're at at should us ALTITUDE-AD, you know you you interim similarly, data waiting as like taking to least on do X Lecanemab, For blinded and If remind months? ARIA everything? go? look expect than your for it's thoughts

Yes. Tom. Thanks,

clarify. So let me

out the blinded in looking of at I the think we data. have study. reporting interim course in of no We're ARIA results anticipation the

II interaction don't with know, that led the to we've think interest well. care notion study essentially that to of if regulatory bodies guided dropped I preserving the the and comment perhaps have of previously or study. we eligibility in the Phase I the a the of we as as has Jim pivotal interims as you using us Eric, that registration run

this Dan, Yes. Jim. is

As integrity statistical study. you power say, the the in I think and us to that what's is important preserving

data pace and completion Dan out continue of because study end. the regulatory the we've most to we important the to that so And the think effective at able read that given and it's a been study the issues highlighted, to enroll and

thing until disclose just the quick of we blinded really to can't reporting. about this comment Obviously, sabirnetug, regarding an a Dan the won't the when is emphasize end we're trial, And trial ARIA but important maybe Yes. ARIA X just for finding and unblinded. this we other results made -- any is ongoing

our And as goes. ARIA as far plan so that's

the will subcu? I subcu you X question do your likely very I Phase appreciate becomes subcu to if Phase subcu. again, a and you your it's need necessity Phase to Or think you a that think do that data with with a enough pivotal II Are it's I last you confident one. forward-looking. for on related And have based pretty

Tom. Sure,

think I we I the for want will see Phase what next before subcu. really step be So the we data predict to

subcu I the what more sabirnetug future. this precisely both committed think providing format. We're in class But to convenient think the program. that well a the advance potentially be IV version will next we that for to is do of of and explore I for required study anticipate available the subcutaneous formats purpose

predict we exactly premature kind it's how again, to will think, proceed. of I

the Our next of of Zemansky America. with Jason line from comes Bank question

Bozdog Cameron for is on Jason. This

maybe of are guess here. you Phase for the would potential what So as gets II I Is indicators ALTITUDE things and it of focus to else? some suggest just underway, we're everything that enrollment? give looking track for the sort on we could something leading is on you investors confidence, looking remains pace

sure. Yes,

question. great So

are in II now time upwards I the half we the quarter enrolled just XXX patient than progressed expecting of to year of announced enrollment have, quickly, rapidly the the enrollment sort mean, of for real anticipated. frame, patients the we has we as of call, next more had the in So first first second the year. we this on complete And rate Phase far in in this study we to set earlier ALTITUDE-AD, mentioned XXXX. And

exciting from next-gen this of results around sabirnetug, the own profile as patients. that oligomers investigators think engagement find a gone safety sabirnetug enrollment for the attribute find that potentially and and And of proof of of expectations, informing So to Phase option and has well. I sort participants I established of mechanism profile a target and treatment we we planning kind that our exceedingly the

of next Pete Fitzgerald. Our line with question the Instructions] comes [Operator Stavropoulos from Cantor

for This online is Samantha Pete.

to into from those in with thinking high So that other you considering show regarding are the of plaque population my into to specific tau anti-amyloid Are higher greater is tau about how ideally likelihood signals. patient patients early ALTITUDE-AD, or certain question would or potentially baseline betas benefit subpopulations the such AD you seen a enrolling levels as efficacy of clinical levels first you tau, like increase low proportion looking findings characteristics ALTITUDE? enroll have Centiloid

be If you could fantastic. that, would that color provide on some

ALTITUDE-AD. going to Eric. I'm address to equipped And direct over best that to question we're population enrolling Sam. the He's in that Thanks,

obviously, it's thinking and time no, lot that I a And question. Dan. a of we've spent great Thanks, about. Yes. guess, And one talking about

as you population is study So Alzheimer's CSF. We cognitive on that cross specific to the for when tau we've dementia case with dementia although, that have or demonstrated targeted did of who or for any in this that the impairment, requirement people know, that watching pathology, patient is based amyloid have line mild our field PET not MCI carefully. pathology mild you

earlier III would response One have suggest earlier these is biomarkers the and in about that of pathology who the talked recent, and larger at have in data things of that the drugs was to based that the their major and studies. a patients we disease Phase better that are an very it's this read out actually some stage on data course that

quite few that in does can things did who read but it And across is One that an and were sensitive lower pushes study that I have a come visual SUVR think of the average a sort of our positive, SUVR. the load, and wouldn't just we your amyloid of an it is human but eye are is important, actually those. PET our SUVR just what reads your measure, between looked people we a you more the on visual based because and at amyloid readings Phase pick up I with were hybrid

data using realized on and less think least at that's visual emerged have amyloid a our pathology you I that a thing. give to Phase data these as we good we So tends read based

feel standard a with we kind relatively loads their now people we the clinical standpoint, we're field seeing amyloid we really with biomarker anticipate dementia, a is standpoint, identify would low SUVR. mild as So from what on based like doing but plaque MCI from people in or of

we'll think based as about exclusion the get at inclusion, data the is as can the on of dialed state you the we the in but end obviously, of So study, current knowledge. criteria well we've

been your follow-up don't when in still lower so think ARIA? waiting view ARIA? comfortable actually ARIA That's to you if waiting far with why great. speaking more has the ARIA physicians, of the impacted We've they And enrollment mind. And thoughts question this past, for Are burden some risk anti-amyloid on administering to with how do study or clinical again how has they ARIA, drugs getting more less sabirnetug? but sidelines with do are X curious burden on on hear the asked you antibodies

Well, yes, another really question. good

was our for Phase So be study. binding our anticipated all premise do the along rates developed specific we to because really we has before plaque, less sabirnetug and more ARIA been lower even I oligomers

And so rates to showed a was the study surprise not fact that I low ARIA, our us. relatively Phase of

study pretty Phase small. replicate we're that need Now at that II in our course, to study. obviously, Phase looking I really We is of carefully. And

that that a get meeting, even using debate about had In ARIA I how these carefully happen of a at rate controversial. something have people the evolving monoclonal good think from different when answers that a all? this but by actually recent clinicians there Sabirnetug of approved should obviously approaching was who it terms think are because really to at how area using itself drugs, bit lower But you've does clinicians, is you'll And people disease-modifying developing antibodies, over fatalities is different rapidly a think thing. should is it question how rapidly it's time. manage of we a about CTAD it's them had if you even starting And

I'm remarks. back queue. Alex would the call over no to gentlemen, further and I for to like turn now showing closing the Ladies in questions

Tawanda who reach Thanks, to If please listened Great. [ feel a day. and out the company, everyone us any free Thanks at today. in remaining are questions, have there to ]. wonderful to always,

Ladies and today's call. gentlemen, for this you concludes participation. your Thank conference

now You disconnect. may