어큐멘 파마슈티컬스(ABOS) 2026년 3분기 실적 발표 전화회의: 11월 ALTITUDE-AD 결과 발표 예정

핵심 요약

• 어큐멘 파마슈티컬스(Acumen Pharmaceuticals)는 사비르네투그의 임상 2상 ALTITUDE-AD 시험에 대한 탑라인 결과를 2026년 11월에 발표할 예정이다.
• 18개월 동안 진행되는 이 임상시험은 1차 평가변수인 iADRS에서 위약 대비 통계적으로 유의미한 차이를 확인하도록 설계되었다. 경영진은 프로그램 진전을 위한 명확한 임상적 성공 기준으로 iADRS상 약 30%의 진행 지연을 제시했다.
• 탑라인 데이터셋에는 CDR-SB(CDR Sum of Boxes), 이상반응, ARIA 발현율, 아밀로이드 PET 영상, p-tau217을 포함한 체액 바이오마커가 포함될 것으로 예상된다.
• 어큐멘의 2026년 3분기 말 기준 현금 및 유가증권은 약 7,900만 달러로, 경영진은 이 자금이 2027년 초까지 현재의 임상 및 운영 활동을 지원할 수 있을 것으로 보고 있다.
• 3분기 R&D 비용은 2,110만 달러였으며, 영업손실과 순손실은 각각 2,580만 달러와 2,540만 달러를 기록했다.
• 회사 측은 뇌 전달 개선 프로그램을 통해 ACU-301 및 ACU-401 개발도 추진 중이며, 2027년 중반에 임상시험계획(IND) 신청이 예상된다.

주요 재무 데이터

사업 및 운영 성과

사비르네투그는 어큐멘의 핵심 임상 파이프라인으로 유지되고 있다. 선택적 항-A베타 올리고머 IgG2 단클론항체인 이 물질은 ALTITUDE-AD 임상에서 4주마다 35 mg/kg 및 50 mg/kg 용량으로 정맥 투여되어 평가받고 있다. 경영진은 두 용량 모두 임상 1상에서의 노출도, 약동학 데이터, 용량 모델링을 바탕으로 선정되었으며, 두 용량 모두 유효 용량 범위에 해당할 수 있다고 밝혔다.

임상 2상은 18개월 치료 후 iADRS를 1차 유효성 평가변수로 사용한다. 어큐멘은 이 연구를 품목허가 신청을 위한 잠재적 구성 요소로 설계했다. 결과가 긍정적일 경우, 회사는 한 건의 확증적 임상 3상 시험을 진행할 것으로 예상하고 있다.

환자 유지율은 경영진의 예상을 상회했다. 대상 자격을 갖춘 참가자의 95% 이상이 12개월간의 공개연장연구 참여를 선택하고 동의했다. 해당 연장 연구의 데이터는 2027년 중에 나올 것으로 예상되며, 초기 탑라인 발표에는 포함되지 않을 가능성이 높다.

어큐멘은 뇌 전달 개선 프로그램을 통해 ACU-301과 ACU-401도 개발하고 있다. ACU-301은 사비르네투그를 이중특이항체 형태로 결합한 것이며, ACU-401은 ACU-234 항체를 활용한다. 비인간 영장류 실험에서 ACU-401은 변형되지 않은 ACU-234에 비해 전두엽 피질 노출도가 최대 40배 높았으며 심뇌 영역에서의 노출도 증가했다.

경영진 가이던스

경영진은 2026년 11월 ALTITUDE-AD의 탑라인 데이터를 발표할 예정이다. 발표 내용에는 1차 및 2차 유효성 결과, 안전성 소견, ARIA 발현율, 영상 및 체액 바이오마커가 포함될 것으로 예상된다.

어큐멘은 약 7,900만 달러의 현금 자산으로 2027년 초까지 현재 활동을 지원할 수 있을 것으로 예상한다. 회사는 2027년 중반 뇌 전달 개선 프로그램에 대한 임상시험계획(IND) 신청을 목표로 하고 있다.

회사는 향후 임상 3상 개발 과정에서 공개연장연구 등을 통해 피하주사 제형을 도입할 가능성이 있다. 최종 접근 방식은 부분적으로 임상 2상 결과와 용량 선정에 따라 달라질 것이다.

리스크 및 주요 관전 포인트

다가오는 ALTITUDE-AD 결과 발표는 수용성 A베타 올리고머를 선택적으로 표적함으로써 알츠하이머병 진행을 완화할 수 있다는 어큐멘의 핵심 가설에 대한 첫 번째 주요 임상 검증이다. 주요 관심사는 18개월 후 어느 용량이든 iADRS에서 통계적으로 유의미한 이점을 가져오는지 여부이다.

안전성 역시 이 프로그램의 이익-위험 프로필에서 핵심적인 요소가 될 것이다. 경영진은 전체적으로 10%대 초반의 ARIA-E 발현율과 유전자형 전반에 걸친 일관된 결과를 예상하고 있으나, 연구는 여전히 블라인드 상태로 유지되고 있어 실제 결과는 아직 확인할 수 없다.

현재의 임상 및 운영 계획상 현금 소진 시점은 2027년 초까지에 불과하다. 한편 임상 3상 개발의 시기와 설계, 피하주사 투여, 그리고 ACU-301 또는 ACU-401의 초기 임상 연구 일정은 ALTITUDE-AD 데이터셋에 의존적이다.

애널리스트 Q&A 주요 내용

• 임상적 성공 기준: 경영진은 18개월 후 iADRS 기준 약 30%의 진행 지연이 확인되면 사비르네투그의 개발을 추진할 근거가 될 것이라고 밝혔다.
• 용량 간 차별화: 35 mg/kg과 50 mg/kg 모두 효과적일 수 있다. 경영진은 50 mg/kg 용량이 아밀로이드 PET 효과를 더 크게 나타낼 가능성이 있다고 언급했다.
• 플라크 제거 후 유지 치료: 수용성 응집체가 병리 현상을 계속 유발할 수 있기 때문에 어큐멘은 플라크 제거 후 올리고머 선택적 항체를 사용하는 것에 대한 과학적 근거가 있다고 보고 있다. 그러나 ALTITUDE-AD는 사비르네투그를 1차 치료제로 평가하는 데 집중하고 있다.
• 초기 치료 효과: 해당 임상에는 독성 올리고머를 중화하는 것이 더 이른 시점에 효과를 나타낼 수 있는지 포착하기 위한 평가가 포함되어 있다. 이 결과는 향후 연구에서 약물 활성을 더 빨리 입증할 수 있을지 판단하는 데 정보를 제공할 수 있다.
• 차세대 파이프라인 개발: ALTITUDE-AD 결과는 뇌 전달 개선 후보물질들의 용량 선정, 바이오마커 전략, 초기 임상 계획을 수립하는 데 도움이 될 것이다.
• 결측 데이터 및 환자 유지율: 경영진은 환자 유지율이 예상을 상회했으며, 결측 데이터는 프로토콜에 정의된 통상적인 방법에 따라 처리될 것이라고 밝혔다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good day, and welcome to the Acumen Pharmaceuticals Third Quarter 2026 Conference Call and Webcast. [Operator Instructions] Please note, this call may be recorded. I would now 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 September 30, 2026. With me today are Dan O'Connell, our Chief Executive Officer; and Matt Zuga, our CFO and Chief Business Officer. They'll have a brief prepared remarks, and then we'll open the call for questions. And 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. Please 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. In the third quarter, our team has been very busy readying for the top line readout from our Phase II ALTITUDE-AD trial investigating our lead product candidate, sabirnetug. If you've been following our company for some time, you're likely well aware that these results are highly anticipated. We are testing our central scientific thesis that arresting the harm done by synaptotoxic amyloid beta oligomers in the brain may offer a differentiated approach to treating Alzheimer's disease. So, today, I'm pleased to confirm that we expect to announce these Phase II results this November.

We are confident that we are fully evaluating the A-beta oligomer hypothesis with this study. ALTITUDE-AD is a large, well-powered Phase II trial with clinically meaningful endpoints. We are testing 2 doses of sabirnetug against placebo, carefully considered based on our Phase I study in Alzheimer's patients, such that either dose may prove efficacious in the Phase II. We have executed the study to a very high operational standard with rapid enrollment, close engagement with study sites and investigators, and high rollover into the open-label extension of the study. As previously mentioned, we envision this study as part of a potential registration package and have conducted the study as such with a single confirmatory Phase III anticipated following positive Phase II results.

As previously outlined, ALTITUDE-AD was designed to detect a statistically significant difference between sabirnetug and placebo on the primary efficacy endpoint, iADRS, following 18 months of treatment. We expect the top line data set to encompass primary endpoint results, key secondary outcomes, including the CDR Sum of Boxes, safety evaluations covering adverse events and ARIA rates, and a range of informative fluid and imaging biomarkers. We believe that sabirnetug has the potential to demonstrate a differentiated benefit-to-risk profile given its unique product attributes as a selective anti-A-beta oligomer IgG2 monoclonal. We look forward to sharing the data in November.

We also continue to advance our enhanced brain delivery program, or EBD, for the treatment of Alzheimer's disease, representing the only program combining a validated blood-brain barrier penetrating technology with an A-beta oligomer selective therapeutic antibody. As a reminder, we are working on 2 candidates in the lead up to an IND filing expected in mid-2027. One candidate, ACU-301, is based on a bispecific antibody incorporating sabirnetug. And ACU-401 incorporates a novel A-beta selective antibody with differentiated properties known as ACU-234. We presented encouraging data at the AAIC meeting in July, showing that after intravenous dosing, all tested EBD bispecific antibodies achieved multifold greater brain exposure than unmodified ACU-234 alone.

ACU-401, in particular, achieved up to a 40-fold greater frontal cortex exposure in nonhuman primates and significant increase in exposures in deep brain regions. The degree of brain penetration we observed in the cynomolgus monkeys combined with the preserved soluble A-beta oligomer selectivity and a clean hematological profile exceeded our expectations and give us confidence in the differentiated potential of our EBD program. The imminent data readout for sabirnetug and the development of our next-generation EBD candidates demonstrate both the robustness of our pipeline and our ability to deliver on key priorities, positioning us for an important period of value-creating milestones ahead, both near and longer term. Again, we look forward to updating you in November. And, with that, I'll turn the call over to Matt.

Matt Zuga

Thanks, Dan. As a reminder, our third quarter 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 third quarter with approximately $79 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 $21.1 million in the third quarter. The decrease over the prior year was primarily due to reductions in manufacturing and materials costs as well as CRO costs, which are both associated with our ALTITUDE-AD clinical trial.

G&A expenses were $4.7 million in the third quarter, roughly flat to the same period in the prior year. This led to a loss from operations of $25.8 million and a net loss of $25.4 million in the third quarter. We look forward to reporting on our Phase II ALTITUDE-AD study next month and remain committed to maximizing the potential of our portfolio of A-beta oligomer targeted antibodies to generate value for patients living with Alzheimer's disease, their caregivers, and our stakeholders. And, with that, we can open the call for Q&A. Operator?

Operator

[Operator Instructions] Our first question comes from Jason Zemansky with Bank of America.

질의응답

Jason Zemansky

Congratulations on the progress. Looking forward to the results. This may seem like a random question now. But as we think about the evolving treatment paradigm, it looks like Biogen is now positioning LEQEMBI as a follow-on after donanemab clears plaque. And the argument is that soluble species, sort of, keep driving disease after the plaque has gone. So, it seems like a natural place for an oligomer selective antibody. How do you think about sabirnetug in addition to, sort of, a primary role, but as a maintenance after plaque clearance or in combination with a plaque clearer? And could anything in the ALTITUDE-AD data set inform that?

Daniel O'Connell

Thanks, Jason. Great question. So, we've always been advocates for chronic dosing, essentially while patients are stable within an early AD stage of disease as we believe these soluble aggregates are present and persistent in driving disease pathology. So, it would be a logical extension to consider sabirnetug or an oligomer selective antibody as a post-plaque clearance follow-on. But we -- so, in the primary mode, we're focused on the primary outcome for sabirnetug in ALTITUDE-AD with an 18-month primary using the iADRS. So, I think we'll have the first case evidence is really out of that Phase II moving towards Phase III, but the therapeutic rationale for sabirnetug as a follow-on would make sense to us as we sit here today.

Operator

Our next question comes from Paul Matteis with Stifel.

Jo Yi Chudy

This is Emily on for Paul. We were just wondering if you could talk a little bit about your dose selection and what might you expect to see in this upcoming readout that would look different on efficacy and safety between those 2 doses?

Daniel O'Connell

Thanks, Emily. Yes. So, for the Phase II, we chose doses of 35 mg/kg and 50 mg/kg, and this is IV dosing every 4 weeks. So, we arrived at those doses as a consequence of the dose exposure and some of the pharmacodynamic effects we observed in the Phase I. So, a combination of the Phase I results with some dose modeling allowed us to select these 2 doses. And importantly, we think both 35 and 50 each are within the zone that could be efficacious.

It may be that the higher dose of 50 mg/kg may have perhaps more observed effects on the amyloid PET signal, but we will see how that reads out in the weeks ahead. We're getting close to that data set. So, very excited to see it. But important to establish that both of these doses, we think, are within that zone of efficacy in conjunction with the safety profile that we think could offer a benefit-to-risk profile that's attractive to patients.

Operator

Our next question comes from Pete Stavropoulos with Cantor Fitzgerald.

Pete Stavropoulos

Congrats on the execution, looking forward to the data next month. A couple for me. I'm wondering what your current thinking is in terms of the bar or what is the minimum we'd like to, sort of, see out of ALTITUDE-AD to move forward, especially since this is the first time that the oligomer hypothesis is being tested. So, the bar for both clinical scales and biomarker data. And what would we expect any OLE data in the readout?

Daniel O'Connell

Thanks, Pete. So, as you may recall, we've been guiding towards a clear clinical success of 30% slowing on the iADRS after 18 months of placebo-controlled period. We think that's a zone in which that would give us the basis for moving forward. And in terms of the safety profile, I mean, the overall adverse event profile, inclusive of ARIA rates and infusion site reactions and other elements of the safety profile that's going to be part of this top line readout. We would anticipate low double-digit ARIA-E in totality and maybe consistent across the genotypes as part of the support of the oligomer hypothesis and the grounds in which sabirnetug would be moving forward to Phase III. So, that's, kind of, how we're thinking about that.

Sorry, your second question, Pete? OLE data. So, yes, as you are good to point out, our open-label extension is a 12-month open-label extension. We've had high rollover. Essentially greater than 95% of people eligible to participate in the open-label extension have elected and consented to do so. That portion of the study will be reading out over an extended period of time. We do think that, that will generate evidence into 2027 and likely won't be part of the top line results. I think important to establish, however, the top line results, as I just mentioned on the scripted call, will be inclusive of the primary and secondary, both efficacy and safety and include biomarker effects, both imaging and fluid.

In terms of the -- we'll be looking at the amyloid PET as a conventional imaging measure. We'll also be looking at fluid biomarkers, CSF and plasma. I think we'll principally be looking at things such as the p-tau217 as a measure of disease status, potentially progression. And I think that's going to be a complete data set to inform stakeholders on the merits of sabirnetug and provide evidence in support of the oligomer hypothesis.

Pete Stavropoulos

All right. And just a question on EBD. How are you thinking about the other path forward for ACU-301 or 401, the MAD/SAD studies? Are you going to go straight into patients or healthy volunteers first and the length of time you, sort of, aim to have patients on the -- in the MAD study? And what optionality do these candidates offer?

Daniel O'Connell

Yes. Thanks, Pete. Well, yes, so, we think there's a lot of optionality in our EBD program. And I think having both 301 and 401 in the mix is really helpful because it affords us a bit of diversity in terms of the profiles and ways to move the program forward. I think we've learned so much in the development of sabirnetug, both initially with INTERCEPT, which was our Phase I study exclusively in Alzheimer's patients that gave us really solid Phase I proof of mechanism data in support of sabirnetug and that, of course, as I just mentioned, informed dosing strategy and the plan for Phase II.

I think the team is still working on refining precisely what we want to do with EBD in the early phase and translational studies. And we'll be looking at the ALTITUDE results, in particular, to assess dosing strategy as well as biomarker strategy for the EBD program. So, we think one of the advantages we at Acumen have is all of the experience we've undertaken with sabirnetug not only through Phase I, but through a robust Phase II, that really serves as a foundation for our strategy for developing the EBD candidates.

Pete Stavropoulos

Congrats on the progress once again.

Operator

Our next question comes from Tom Shrader with BTIG.

Thomas Shrader

I guess we'll all hold our breath for 30 days. But I think one of the interesting things about sabirnetug is that it might act faster given the monomer binding, things like that. And the question is, how set up are you to capture that? When are you looking at patients? When are you scanning? When are you taking soluble biomarkers? I think a fantastic readout from this might be that your next Phase III could be shorter because the drug works faster. And the question is, how set up are you to catch some sort of readout like that?

Daniel O'Connell

Thanks, Tom. So, with sabirnetug's high selectivity for toxic A-beta oligomers, we do hear the thesis holds that neutralizing those toxic species early in the early course of disease could have not only a slowing of disease, but some other potentially, sort of, symptomatic benefit. I think that's an interesting possibility. I do know that our plans have incorporated elements of observing or essentially capturing that possibility.

So, I think we will know a lot in the coming weeks as the ALTITUDE reads out as to whether, given the mechanism, there is a potential to look at earlier time points for establishing a drug effect going forward. So, yes, it's a really -- as you mentioned, we think ALTITUDE is a robust test of this central scientific hypothesis and are eagerly awaiting the unblinding and the interpretation of those results.

Operator

Our next question comes from Geoff Meacham with Citi.

Mary McKeown

This is Mary Keown on for Geoff. Could you speak to some of the KOL feedback you're receiving on sabirnetug and the ALTITUDE-AD program? Maybe what are physicians looking for in a treatment? And how could sabirnetug address these needs? And then just as another one, maybe what feedback do they have on the mechanism here as well?

Daniel O'Connell

Great. So, in our travels and interactions with KOLs, I mean, they're mostly principally focused on better treatment options for patients. And I think as such, sabirnetug, with a different mechanism, not a plaque-busting agent, but rather something that targets these soluble toxic species, is something of high interest and given that potential.

So, they are keenly -- as is everybody in the field, I think, kind of, looking at ALTITUDE as a differentiated study where sabirnetug could shift some people's thinking on what the primary mode of treatment should be, whether it be oligomers versus plaque and so forth. So, we think there's a lot of anticipation going into next month's readout. And we do think that the study has a mix of data outcomes and readouts that will be very informative as to the merits of sabirnetug and underpin the attractiveness of targeting toxic oligomers in a primary, selective and direct fashion.

Operator

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

Dev Prasad

Congrats on the progress. A couple of questions. One is, as we approach the readout, can you comment on patient retention? And maybe how should we think about the impact of missing data or discontinuation on primary efficacy analysis? And another one is on subcutaneous. I believe the subcu work was on hold until the dosage chosen. So, wondering, do you plan to initiate that work after the Phase II trial?

Daniel O'Connell

Thanks, Dev. So, in terms of retention in the primary ALTITUDE-AD study, as we mentioned, we've conducted the study to a very high standard. We have -- our retention within the primary portion of the study has exceeded, sort of, our expectations, which is great, and we've had high rollover into the open-label extension. So, just objectively, we think people that are participating in the study like the study and have been inclined to stay in and/or extend their involvement in the study. So, that's encouraging. And yet it's obviously still blinded data.

In respect to your question on missing data, I think we will be addressing those issues in a, kind of, conventional and per protocol basis. So, I don't know that there's more I can offer -- more specifics I can offer on that question.

And thirdly, in terms of the subcu, yes, we completed a healthy volunteer, essentially a bioavailability study back that read out in early '25. We think we have what we need in terms of the contrast between IV dosing, subcutaneous dosing of the sabirnetug formulation. We anticipate using the Phase III in one direction or another to incorporate a subcutaneous advancement. And I think you can look at some predicates out there, if you look at what Eisai and Biogen did with LEQEMBI, incorporating the subcu as part of the open-label extension in Phase III, that could be analogous to how we would be moving forward in the future with a subcutaneous option.

Operator

This concludes the question-and-answer session. Thank you for your participation. You may now disconnect. Good day.