어큐멘 파마슈티컬스(ABOS) 2026년 2분기 실적 발표회: ALTITUDE-AD 결과 발표 2026년 말 예정

어큐멘 파마슈티컬스(NASDAQ: ABOS)는 2026년 2분기 실적 발표 콘퍼런스 콜에서 사비르네투그(sabirnetug)의 임상 2상 ALTITUDE-AD 결과 발표에 집중했습니다. 한편 회사는 1억 1,020만 달러의 현금 및 유가증권을 보유하고 있으며, 경영진은 이를 통해 2027년 초까지 현재 운영 활동을 지원할 수 있을 것으로 예상하고 있습니다.

핵심 요약

• 어큐멘은 임상 2상 ALTITUDE-AD 시험의 톱라인 결과를 2026년 하반기에 발표할 수 있을 것으로 계속 전망하고 있습니다.
• 톱라인 데이터셋에는 1차 평가변수인 iADRS를 비롯해 CDR-SB, 안전성 및 ARIA 발현율, 체액 및 영상 바이오마커가 포함될 것으로 예상됩니다.
• 2분기 연구개발(R&D) 비용은 2,780만 달러, 일반관리비(G&A)는 470만 달러를 기록했습니다. 순손실은 총 3,270만 달러에 달했습니다.
• 2026년 6월 30일 기준 현금 및 유가증권은 1억 1,020만 달러로, 2027년 초까지 자금 운용이 가능할 것으로 예상됩니다.
• 영장류 대상 시험에서 ACU401은 수정되지 않은 ACU234 대비 전두엽 피질 노출량이 최대 40배 높게 나타났습니다. 어큐멘은 선두 뇌 전달 향상 후보물질에 대해 2027년 중반 임상시험계획(IND) 신청을 목표로 계속 추진하고 있습니다.
• 임상 2상 결과 발표를 앞두고 사비르네투그, EBD 프로그램 및 어큐멘의 투자 포인트를 점검하기 위해 9월 16일 온라인 기업설명회(IR Day)가 예정되어 있습니다.

주요 재무 데이터

사업 및 운영 성과

ALTITUDE-AD, 핵심 임상 2상 모멘텀 임박

ALTITUDE-AD는 18개월 동안 위약 대비 사비르네투그 35mg/kg 및 50mg/kg 용량을 평가하고 있습니다. 두 유효 용량 모두 이전 연구에서 약동학적 타깃 결합을 달성한 것으로 확인된 노출 범위에 해당합니다.

1차 임상 유효성 평가변수는 인지 및 기능 평가 결과를 결합한 종합 지표인 iADRS입니다. 경영진은 2026년 하반기 톱라인 결과 발표에 CDR-SB, 이상반응, ARIA 발현율, 체액 및 영상 바이오마커도 함께 포함될 것으로 예상하고 있습니다.

어큐멘은 임상 1상 연구에서 3회 투여 후 아밀로이드 베타 올리고머 타깃 결합 및 바이오마커 변화를 확인했다고 밝혔습니다. 경영진은 사비르네투그가 가용성 아밀로이드 베타 올리고머를 선택적으로 타깃팅하고 IgG1 항체보다 작동기 기능이 적은 IgG2 항체 형태를 사용하기 때문에 차별화된 이점 대비 위험 프로필을 제공할 수 있을 것으로 보고 있습니다.

뇌 전달 향상 파이프라인 진전

어큐멘은 JCR 파마슈티컬스와의 공동 연구의 일환으로 ACU301 및 ACU401을 뇌 전달 향상 후보물질로 선정했습니다. ACU301에는 사비르네투그가 포함되어 있으며, ACU401에는 차세대 올리고머 선택적 항체인 ACU234가 적용되어 있습니다.

영장류 시험에서 테스트된 3종의 EBD 이중항체 모두 수정되지 않은 ACU234보다 더 높은 뇌 노출량을 보였습니다. 특히 ACU401은 전두엽 피질에서 최대 40배 더 높은 노출량을 기록했으며, 뇌 심부 영역에서의 노출 증가, 가용성 아밀로이드 베타 올리고머에 대한 선택성 유지, 깨끗한 혈액학적 프로필을 나타냈습니다.

회사는 두 후보물질 모두에 대해 개발 작업을 계속하고 있지만, 전체적으로 가장 뛰어난 프로필을 바탕으로 하나를 선별해 임상 개발에 진입시킬 예정입니다. 후보물질 최적화 과정에는 트랜스페린 수용체 결합력, 일가 대 이가 구조 선택, 뇌 전달력, 빈혈 발생 위험성 등이 검토됩니다.

경영진 가이던스

• ALTITUDE-AD 톱라인 결과는 2026년 하반기 발표될 예정입니다.
• 어큐멘은 현재의 현금 자산으로 2027년 초까지 임상 및 운영 활동을 지원할 수 있을 것으로 기대하고 있습니다.
• 회사는 선두 EBD 후보물질에 대해 2027년 중반 IND 신청을 진행할 것이라는 전망을 유지하고 있습니다.
• 경영진은 성공적인 임상 2상 결과가 나올 경우 이후 임상 진입까지의 공백 기간을 줄이기 위해 임상 3상 준비 작업을 진행하고 있습니다. 다만 임상 3상 디자인에 대한 최종 규제당국 협의 작업은 ALTITUDE-AD 데이터에 따라 달라질 예정입니다.

위험 요소 및 주시해야 할 항목

• 어큐멘은 ALTITUDE-AD 시험의 두 유효 용량에 대한 구체적인 통계적 검출력이나 분석 가정을 공개하지 않았습니다. 경영진은 두 용량 모두 유효성을 입증할 가능성이 있다고 밝혔습니다.
• 투자 가치는 임상 유효성, 안전성, ARIA 발현율 및 바이오마커 결과를 포함하여 2026년 하반기로 예정된 임상 2상 결과에 크게 의존하고 있습니다.
• ACU301과 ACU401 중 최종 선정안은 아직 확정되지 않았으며, 초기 임상시험 디자인도 계속 논의 중입니다.
• 경영진은 실제 환자에게 최대한 신속하게 적용하는 것을 목표로 하고 있으나, EBD 프로그램을 건강한 지원자를 대상으로 시작할지 아니면 환자 대상 임상으로 바로 진입할지는 아직 결정하지 않았습니다.
• 디지털 트윈 분석 및 MTBR-tau243과 같은 신규 바이오마커는 여전히 탐색 단계에 있으며, 보관된 검체를 활용해 소급적으로 평가될 가능성이 있습니다.

애널리스트 Q&A 하이라이트

• ALTITUDE-AD 결과 발표: 경영진은 톱라인 결과에 1차 평가변수뿐만 아니라 iADRS, CDR-SB, 체액 및 영상 바이오마커, 안전성 평가 지표가 포함될 예정임을 확인했습니다.
• 임상 3상 준비: 어큐멘은 CMC(제조품질관리), 파트너사 협의, 임상기관 관련 계획을 진행하고 있으나, 임상 3상 디자인에 대한 확정적인 규제당국 논의는 임상 2상 결과에 따라 결정될 예정입니다. 회사는 긍정적인 결과가 나올 경우 단일 핵심 임상 3상 시험 진행의 기반이 되기를 기대하고 있습니다.
• 안전성 차별화: 경영진은 사비르네투그의 올리고머 선택성과 IgG2 형식이 면역 활성화를 줄이고 차별화된 ARIA 프로필을 나타낼 수 있는 요인이라고 강조했으나, 이에 대한 최종 확인은 ALTITUDE-AD 결과에 달려 있습니다.
• 바이오마커: 환자 선별에 p-tau217이 사용되었으며 향후 결과 평가변수로도 분석될 예정입니다. 아울러 보관된 혈장 샘플을 통해 추후 MTBR-tau243 및 기타 신규 혈액 기반 바이오마커에 대한 분석도 가능할 수 있습니다.
• 디지털 트윈: 언런.AI(Unlearn.AI)와의 협력은 환자 선별에서의 활용 가능성을 평가하고 향후 분석에서 예후 공변량으로 활용하기 위한 탐색적 평가변수로 사용되고 있습니다.
• 병용 요법 전략: 경영진은 병용 치료를 알츠하이머병의 장기적 치료 방향으로 보고 있으며, 아밀로이드 베타 올리고머 포트폴리오와 더불어 타우 표적 또는 소염 작용 방식의 치료 기회를 평가해 나갈 계획입니다.

실적 발표 콘퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good day, and welcome to the Acumen Pharmaceuticals Second Quarter 2026 Conference Call and Webcast. [Operator Instructions] Please note this call is being recorded.

I would like to turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.

Alex Braun

Thanks, Michelle. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended June 30, 2026. With me today are Dan O'Connell, our Chief Executive Officer, and Matt Zuga, our CFO and Chief Business Officer. They will have brief prepared remarks, and then we'll open the call for questions. Joining for the Q&A session, we also have Dr. Jim Doherty, our President and Chief Development Officer, and Dr. Eric Siemers, our Chief Medical Officer.

Before we begin, we encourage listeners to go to the Investors section of the Acumen website to find our press release issued this morning that we'll discuss today. Please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. You will see Slide 2 of our corporate presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments.

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

Daniel O'Connell

Great. Thanks, Alex. Good morning, everyone, and thanks for joining us today. During the second quarter, our focus remained on disciplined execution as we advanced sabirnetug towards the highly anticipated topline readout from our Phase II ALTITUDE-AD trial, which we continue to expect late this year. We believe this will be an important efficacy readout in the Alzheimer's field. ALTITUDE-AD remains a critical test of our central scientific thesis that selectively targeting synaptotoxic amyloid-beta oligomers may offer a differentiated approach to treating Alzheimer's disease. A substantial body of evidence supports this hypothesis, and we are excited by the opportunity to evaluate that thesis in a well-powered, randomized Phase II study with clinically meaningful endpoints.

Our Phase II results have the potential to substantially expand on our Phase I results, which included demonstration of A-beta oligomer t arget engagement and biomarker changes that we're seeing as early as 3 months of treatment, as we previously reported. We continue to be encouraged with the engagement of patients, caregivers, investigators, and study sites participating in ALTITUDE-AD, as well as in its 12-month open-label extension study. Their commitment has been instrumental in bringing us to this important inflection point. I believe the strong relationships the Acumen team holds with study sites and investigators is particularly supported by Acumen's patient-centric approach.

At AAIC last month in London, we presented patient experience data collected from participants and study partners prior to treatment in ALTITUDE-AD. Results illustrate the diverse ways individuals with early Alzheimer's disease experience, respond to, and cope with cognitive and functional changes, underscoring the importance of capturing patient experience directly to better understand the meaningful benefit at this stage of disease. As we previously described, ALTITUDE-AD was designed to detect a statistically significant difference on its primary clinical efficacy endpoint, iADRS, after 18 months of treatment with sabirnetug compared with placebo. We expect the topline dataset to include results from the primary endpoint, key secondary measures such as the CDR-SB, safety assessments including adverse events and ARIA rates, as well as important fluid and imaging biomarkers.

The study is evaluating two dose levels, 35 mg/kg and 50 mg/kg, compared with placebo. Both these dose levels are within the exposure range previously shown to achieve pharmacodynamic target engagement. While we remain focused on execution and preparation for the readout, enthusiasm across the organization continues to build as we approach this landmark catalyst. We believe that sabirnetug has the potential to demonstrate a differentiated benefit-to-risk profile given its unique product attributes as an anti-A-beta oligomer IgG2 monoclonal. We look forward to sharing the results later this year.

In the second quarter, we announced the nomination of two enhanced brain delivery candidates for the treatment of Alzheimer's disease, representing the only program combining a validated blood-brain barrier penetrating technology with an anti-A-beta oligomer-selective therapeutic antibody. Building on robust preclinical data from both in vitro and in vivo studies, we exercised our options with JCR Pharmaceuticals and will advance two candidates, ACU301 and ACU401. ACU301 is a bispecific antibody incorporating sabirnetug, and ACU401 incorporates a novel next-generation A-beta oligomer-selective antibody with differentiated properties. This is known as ACU234. We view our EBD program as expanding the optionality in our pipeline and will continue to evaluate both candidates in the lead-up to support a filing of an IND. Confirming our mouse data in non-human primates is a pivotal step in this work.

At last month's AAIC conference, we presented data showing that after intravenous dosing, all three EBD bispecific antibodies achieve greater brain exposure than unmodified ACU234 alone. ACU401, in particular, achieved up to a 40-fold greater frontal cortex exposure in non-human primates and significant increase in exposures in deep brain regions. The degree of brain penetration observed in cynomolgus monkeys, combined with preserved soluble A-beta oligomer selectivity and a clean hematological profile, exceeded our expectations and gives us confidence in the differentiated potential of our EBD program's approach. We continue to anticipate an IND filing for our lead EBD candidate in mid-2027.

Coming up, I'd like to flag for investors an anticipated virtual Investor Relations Day to be held on September 16. Please mark your calendars to view live or as a recording, as we hope this will be a helpful review for the Acumen investment thesis prior to ALTITUDE-ADPhase II data readout. The advance of sabirnetug and our next-generation blood-brain barrier EBD candidates underscores the strength of both our scientific platform and our ability to execute, positioning us well for a significant, eventful remainder of 2026. I look forward to updating you on our program and on our Phase II results for sabirnetug late this year.

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

Matt Zuga

Thank you, Dan. As a reminder, our second quarter of 2026 financial results are available in the press release we issued this morning, and in our 10-Q we will file later today. We ended the second quarter with $110.2 million in cash and marketable securities on our balance sheet, which is expected to support our current clinical and operational activities into early 2027. R&D expenses were $27.8 million in the second quarter. The decrease over the prior year was primarily due to reductions in manufacturing and materials costs as well as CRO costs as we get into the final leg of our clinical trial.

G&A expenses were $4.7 million in the second quarter, roughly flat for the same period in the prior year. This led to a loss from operations of $32.6 million and a net loss of $32.7 million in the second quarter. We are confident in our scientific innovation and strong track record of execution as we work toward our Phase II ALTITUDE-AD readout later this year and advance our EBD program. We remain dedicated to building value with our portfolio of A-beta oligomer-targeted antibodies for Alzheimer's patients, caregivers, and stakeholders.

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

Operator

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

질의응답

Matthew Ryan Tan

This is Matthew on for Paul. I guess another company doing an oligomer-specific approach read out some blinded data recently. Maybe can you talk about like what are the differences between their approach versus yours and trial design, and how much can we, you know, kind of read through on their clean safety to your upcoming data?

Daniel O'Connell

Hey, Matthew, thanks for the question. Yes, we saw the announcement of the blinded interim assessment, but this is really early-stage data. So there's not too much we can conclude from that reporting or that announcement. And we'll be interested to see how that study reads out sometime early next year. We reported Phase I results in 2023, which, to our view, established a really robust clinical target engagement of A-beta oligomers. And with just 3 doses in that Phase I study, we're seeing effects on both fluid and imaging biomarkers that sort of exceeded our expectations and underpin our confidence in why in a large study, in an efficacy-based study such as ALTITUDE-AD, sabirnetug is positioned for success.

Matthew Ryan Tan

Okay. And maybe a quick follow-up. In the selection of your EBD candidates, what were the parameters that you sought to optimize? And where do you think your second molecule might be better than the bispecific sabirnetug?

Daniel O'Connell

Thanks. I can quickly comment. I mean, I think for our EBD program, we envision from a product profile standpoint, subcutaneous administration as a convenient form for delivery, as well as preserving the oligomer selectivity, potentially enhancing that selectivity, and an efficient transport across the blood-brain barrier using the transferrin carrier technology as partnered with JCR. So I think we're looking at safety, efficacy, and broader exposure in a format that would lend itself to convenient sub-Q dosing. So both of the candidates have, at least so far, demonstrated all of those attributes, and some of that data has been presented at meetings, and we'll continue to report on findings in that program as we march towards an IND filing on a lead sometime in mid-'27.

James Doherty

Matthew, this is Jim. Maybe I can add a little bit to what Dan has been saying. Of course, when you see the candidates that we announced, those represent the sort of culmination of a process. And we had a really robust collaboration with JCR. And what it allowed us to do is really look at a bunch of different parameters for optimizing for the right fit to match the carrier and the cargo to come up with the final product. And so we looked at a number of things. We looked at affinity for TfR. We looked at valency, monovalent versus divalent. We looked at a bunch of parameters around the potential risk for anemia and things like that. And so it really represents the culmination of a whole campaign to optimize for what we think is the best fit to deliver these oligomer-targeting antibodies into the CNS.

Operator

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

Jason Zemansky

You described ALTITUDE, I guess, as designed to detect a stat-sig difference in iADRS, but with two active doses, can you clarify the framework and whether each dose is independently powered against placebo? If only one succeeds, under what circumstances would constitute a statistically robust positive study? And then a quick follow-up, please.

Daniel O'Connell

Thanks, Jason. Good question. As we have not specifically provided details on the powering and the analysis. I think, I don't know that we can go into greater detail on that this morning. Yes, we do have both doses, both of which have demonstrated target engagement. We think both of these doses could emerge as efficacious doses, and we'll be looking forward to providing more information as we get closer to the data readout later this year.

Jason Zemansky

Got it. And then maybe without getting too much into the efficacy bar, can you speak to the work you're doing now to minimize the interval between the Phase II results and the initiation of a Phase III? Any regulatory engagements, CMC, partner discussions, site planning? Which activities are sort of gated until the data?

Daniel O'Connell

Thanks, Jason. Well, you can imagine there are elements of everything that you mentioned that are ongoing now, with the exception perhaps of regulatory interactions in terms of establishing the Phase III design and so forth. But there's a lot of activity and anticipation to minimizing the white space. And we're hopeful for a successful readout in ALTITUDE-ADthat really will help facilitate and accelerate our ability to move sabirnetug into a single pivotal Phase III.

Operator

Our next question comes from Pete Stavropoulos with Cantor.

Samantha Schaeffer

Hi, this is Samantha on the line for Pete. My first question is there are biomarker data that suggests certain tau fragments like p-tau217 can be used as a marker for amyloid pathology, while markers like MTBR-tau243 identifies tau tangle pathology in Alzheimer's disease. I know that you've incorporated and will look at p-tau217 in the ALTITUDE-ADstudy, but can you talk about tau243? Do you plan to look at it in ALTITUDE, and how could you incorporate it into a Phase III? Can it be leveraged to help or expedite patient selection?

Daniel O'Connell

Thanks, Samantha. Go ahead, Eric.

Eric Siemers

Yes, so this is Eric Siemers. Maybe I can take that one. So, yes, the biomarker world in Alzheimer's is moving really quickly, especially with regard to blood-based biomarkers. As I think you probably know we use p-tau217 as part of our screening procedure actually for enrolling people into ALTITUDE, but it'll also be an outcome measure that we'll look at after we're unblinded at the end of the study.

MTBR is relatively newer, and so it really wasn't being discussed at the time we designed ALTITUDE. But one of the things that we have talked about is that, we have, a large number of patients and a lot of actually plasma samples that will be stored. And so we have the opportunity to look at things like MTBR, new biomarkers that, especially the blood-based biomarkers, that become interesting after we actually complete the study.

So yes, MTBR is one of the things we talk about, but I think it's not just that. Any other new blood-based biomarker that may look interesting, we'll have the opportunity to look at.

James Doherty

And Samantha, this is Jim. Maybe just to add a little bit onto what Eric is saying. I think he's totally right. It's really an exciting time in the field for looking at these fluid-based biomarkers. And the reason for that is it really provides a lot of information about patients. And so I think what we're seeing is people are beginning to measure these multiple markers in a lot of different studies, looking at a lot of different things. It potentially gives you the opportunity to look at where a person is in their progression with disease. It has the ultimate potential, I think, to start identifying patients who might be better candidates than others.

I think we're too early days for those kinds of applications, but I do think that's where the field is going. And so what we'll do exactly as Eric is saying, is as we go along, we'll continue to monitor all this. We'll use these tools as we can in our trials, and we have the opportunity to go back and measure some of these things, even in a post hoc fashion. So I think this is going to continue to be an important part of Alzheimer's trials moving forward.

Samantha Schaeffer

Awesome. And just one quick follow-up. In July, there was an announcement of a collaboration with Unlearn utilizing digital twins. Can you help us understand what this tool is and how it's incorporated into the Phase II, and how can you possibly leverage it for Phase III?

James Doherty

Yes, absolutely. This is Jim again. I'm happy to take that one. As you say, we have partnered with a company called Unlearn.AI to use these digital twins. And we see it again as another tool, another emerging tool that potentially provides some value. Essentially, these are almost individualized digital models relying on the data from thousands and thousands of patients who have been studied for the progression of their disease in clinical trials and in other formats. And so at this point, there's a tremendous amount of data about how disease progresses over time. And of course, it's incredibly complex and differentiated patient to patient. But what these tools do is allow for using baseline data to predict how their individual course of disease will progress over time.

It's a model, and I think there have to be lots of questions about how robust the models are, what you can say about them, what you can't say about them, but potentially, they have the opportunity to do things like allow you to refine your patient selection. They have the opportunity to do things like be used as a prognostic covariate in analyses following trials. And I think there are a number of potential applications, but honestly, the only way to really evaluate how much value these things have is to begin to get in there and work with it yourself. And so that's effectively what we're doing.

We're using this at this point as an exploratory endpoint. We're trying to understand how these tools might be useful to us in the future. And I think, as I was saying, there are several potential ways they can be used. So that's what our evaluation will be to understand which ones are the best ways to apply this technology for Acumen.

Operator

Our next question comes from Thomas Shrader with BTIG.

Thomas Shrader

A little background or next steps on the EBD franchise. Do you anticipate you would take both candidates into humans? Do you have to start with healthy volunteers? And any sense of how many patients or people you would need to get a read on anemia?

Daniel O'Connell

Thanks, Tom. Jim, why don't you take that one as well?

James Doherty

Yes, happy to. Some great questions, Tom. These are things that the team is actively working on at this point. To the first question, we have identified and nominated two candidates, ACU401 and ACU301. We're doing work on both molecules, and it really is intended to identify which one offers what we think is the best overall profile. So what we would intend to do is move into clinical development with one molecule, and that'll be the one that we think offers the best of possible profiles.

As far as additional work that we're doing, there's a tremendous amount of work on CMC and on tox study preparation in preparation for our plan to file an IND in mid-2027. And, I think we're still working on study design. There's a lot of active discussion around it. We've got a lot of experience from the INTERCEPT-AD study with sabirnetug that is going to help us identify what's exactly the best trial design to use. I think what I could say at this point is it's really going to come down to what's the most efficient design. We are going to try to get as much information as we can as we did in the INTERCEPT-AD study, but we also wanted to move this exciting program forward as quickly as we can. So more details later on what those design choices are going to turn out to be. But I can tell you there's a lot of active discussion right now with the program team trying to land what is going to be the most efficient design.

Thomas Shrader

And are you going to start in healthy volunteers or are you not saying?

James Doherty

So, that's one of the things that we're going to see. I think the goal is to transition to patients as quickly as we think is practical because you get a lot of valuable information from patients, as in INTERCEPT-AD. But I think, exactly when that would be is honestly one of the things that we're still talking about. So, yes, I just, we haven't really made a final decision yet.

Thomas Shrader

And one quick one for Dan. Do you expect to go radio silent at some point? And any guidance about when?

Daniel O'Connell

So, Tom, we continue to be convinced we'll have the topline results for ALTITUDE-AD late '26, consistent with our guiding for some time now. We have mentioned, as I mentioned on the call, we'll have an Investor Relations Day, September 16. And that'll be a forward-looking public-facing discussion. We anticipate participating in some of the early fall activities. So we'll be visible and accessible at some point as we get closer to the end of the year. In the fourth quarter, I think we will probably have to shut down some of our public-facing engagement in anticipation of results. But the timing and specific dates for that, can't comment on.

Operator

Our next question comes from Geoff Meacham with Citi.

Geoffrey Meacham

I have two quick ones. The first, I know the focus on oligomers obviously differentiates you from Kisunla and Leqembi, but how would you set expectations on safety and tolerability and the differences there? I guess, particularly as we get more real-world experience with these two agents in the industry commercially.

Second question, I want to get your view of the recent competitor tau data when you kind of think about the post-ALTITUDE-ADdata. Is there a way to fast track perhaps a combo proof of concept if you think that's a viable strategy?

Daniel O'Connell

Thanks, Geoff. Good questions. I think in terms of safety, tolerability, and sabirnetug, as we described, ALTITUDE-ADwith two active doses is intended to demonstrate a clinical efficacy signal and a risk-benefit profile, both inclusive of the clinical efficacy relative to safety that is differentiated from existing treatments. So we're hopeful and enthusiastic about that possibility. And really just the magnitude of the study, the duration of exposure, we think it's a well-designed study to underpin and validate the oligomer hypothesis as we've positioned it. So that's sort of our expectations for sabirnetug and ALTITUDE.

I think that you mentioned the, I think that you're referring to the Biogen BIIB080 program that was reported at AAIC in July. And I think those are interesting data. It looks as though they'll move into a Phase III study for that molecule. And I think it serves as, depending on how you view it, the first clinical validation of a tau-directed approach. Ultimately, I think we take the view that Alzheimer's is a disease that will be more adequately addressed with combination strategies. So we'll continue to evaluate ways to leverage not only our portfolio of A-beta oligomer-directed approaches or treatments with other potentially synergistic combinations whether it be tau or anti-inflammatory approaches, but it just sort of underpins sort of the stage we're at in terms of establishing better treatment options for patients.

We think the future is quite bright for safer, more efficacious, and more robust treatment for the early stages of the disease. And as I'm sure folks on the call are aware, the move into the preclinical population, and hopefully a way to avert or otherwise delay the onset of symptoms. So it is a really robust innovation ecosystem right now in the space, and we think that will continue to accelerate both commercially with products being adopted and grown in the marketplace and then with further research innovations that will continue to build on better options for patients.

Eric Siemers

Yes, and this is Eric. If I could just expand on that a little bit. In terms of safety and tolerability, there's sort of two aspects of that that are differentiated with sabirnetug. So first of all, it's the target. It's very selective for oligomers rather than plaque, and we think that that has some potential benefits in terms of safety. And the other thing that is important to keep in mind, I think, is that this is an, what's called an IgG2 antibody rather than an IgG1 antibody. Without going into too many details, the IgG -- all the other monoclonal antibodies are IgG1s, and they have more what's called effector function.

In other words, they call in your immune system to get rid of things that you don't want there. In the case of these monoclonals, it's typically plaque. And that can lead to problems like ARIA. But for an IgG2, there's less of this effector function, so it's less effect on calling in immune cells. And for our mechanism, targeting oligomers, you really don't need that to happen anyway. So there's two reasons to think that our safety and tolerability could be quite good. One is that we have this differentiated target, oligomers, and the second is that we have an IgG2 antibody with less effector function and less immune system activation. So we're looking forward to seeing the data from ALTITUDE, obviously.

Operator

Our next question comes from Dev Prasad with Lucid Capital Markets.

Dev Prasad

Just a couple of follow-up questions. First is to follow up on the biomarker data question. Will that biomarker data be in the topline release or will it follow later? And the second is, what should we expect from September 16 IR Day? Will it include new EBD data or a preview of ALTITUDE-ADanalysis plan or a venue to select EBD lead candidates?

Daniel O'Connell

Thanks, Dev. So for your first question, the topline results, as I mentioned in the prepared remarks, will include the primary outcome, the iADRS, which is a composite including both cognitive and functional measures involving the ADAS-Cog as well as the ADCS Activities of Daily Living. We'll also have the CDR Sum of Boxes, again, another cognitive functional endpoint familiar to the agency and others in the field. We intentionally will include both fluid and imaging biomarkers as part of those topline results. We really want the ALTITUDE-ADreadout to be a robust readout that really determines sabirnetug's safety and clinical efficacy as part of the study design. So, yes, we do anticipate having both imaging and fluid biomarkers with the topline results late this year.

Alex Braun

And then for IR Day, yes, so I would expect that to be more of a review of the investment thesis of Acumen. So whoever would like to get up to speed on sabirnetug and our EBD program prior to that Phase II data, that would be a good event for, viewers to tune into. So, yes, please keep it on your calendar.

Operator

I'm showing no further questions at this time. I'd like to turn the call back over to Alex Braun for closing remarks.

Alex Braun

Thanks, Michelle, and thanks to everyone for tuning in today. As always, we are at the company for follow-up questions, and I hope everyone has a wonderful day.

Operator

Thank you for your participation. You may now disconnect.