Acumen Pharmaceuticals Q3 2026 Earnings Call Transcript

Acumen Pharmaceuticals (NASDAQ:ABOS) reported third-quarter financial results on Monday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Acumen Pharmaceuticals anticipates the release of Phase 2 ALTITUDE-AD trial results for its lead product candidate, sabirnetug, in November 2026. Sabirnetug targets amyloid beta oligomers for Alzheimer’s treatment.

The company ended Q3 2026 with $79 million in cash and marketable securities and expects to fund operations into early 2027. R&D expenses were $21.1 million, while G&A expenses were roughly flat at $4.7 million.

Future strategic initiatives include the Enhanced Brain Delivery program with candidates ACU301 and ACU401, aiming for an IND filing in mid-2027 and leveraging blood-brain barrier-penetrating technology.

Management highlighted confidence in sabirnetug’s differentiated benefit-to-risk profile and potential registration following positive Phase 2 results, with a single confirmatory Phase 3 planned.

Key opinion leaders are optimistic about the novel approach of sabirnetug, which targets soluble amyloid beta oligomers and offers potential advantages over plaque-targeting treatments.

Full Transcript

OPERATOR

Good day and welcome to the Acumen Pharmaceuticals third quarter 2026 conference call and webcast. At this time, all participants are in listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. To ask a question, you will need to press star 11 on your touchtone telephone. Please note this call may be recorded. I would like to turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.

Alex Stepanek Braun (Head of Investor Relations)

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 brief prepared remarks and then we’ll open the call for questions. 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 (Chief Executive Officer)

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 2 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 2 results this November. We are confident that we are fully evaluating the Aβ oligomer hypothesis with this study. ALTITUDE-AD is a large, well-powered Phase 2 trial with clinically meaningful endpoints. We are testing two doses of sabirnetug against placebo, carefully considered based on our Phase 1 study in Alzheimer’s patients, such that either dose may prove efficacious in the Phase 2. 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 3 anticipated following positive Phase 2 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 dataset 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–Aβ 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 Aβ-selective therapeutic antibody. As a reminder, we are working on two candidates in the lead up to an IND filing expected in mid-2027. One candidate, ACU301, is based on a bispecific antibody incorporating sabirnetug, and ACU401 incorporates a novel Aβ-selective antibody with differentiated properties known as ACU234.

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 ACU234 alone. ACU401 in particular achieved up to a 40-fold greater frontal cortex exposure in nonhuman primates and significant increases in exposures in deep brain regions. The degree of brain penetration we observed in cynomolgus monkeys, combined with the preserved soluble Aβ oligomer selectivity and a clean hematological profile, exceeded our expectations and gives 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 (Chief Financial Officer and Chief Business Officer)

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 second quarter. Excuse me. 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 2 ALTITUDE-AD study next month and remain committed to maximizing the potential of our portfolio of Aβ 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

Thank you. As a reminder, to ask a question, please press star 11. If your question has been answered and you’d like to remove yourself from the queue, press star 11 again. Our first question comes from Jason Zymanski with Bank of America. Your line is open.

Jason Zymanski (Analyst at Bank of America)

Good morning. 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 is 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 dataset inform that? Thanks so much.

Daniel O’Connell (Chief Executive Officer)

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-up. So in the primary mode, we’re focused on the primary outcome for sabirnetug in ALTITUDE with an 18-month primary using the iADRS. So I think we’ll have the first case evidence really out of that Phase 2 moving towards Phase 3. But the therapeutic rationale for sabirnetug as a follow-on would make sense to us as we sit here today.

Jason Zymanski (Analyst at Bank of America)

Thanks so much for the color.

OPERATOR

Thank you. Our next question comes from Paul Matisse with Stifel. Your line is open.

Emily (Analyst at Stifel)

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

Daniel O’Connell (Chief Executive Officer)

Thanks, Emily. Yeah, so for the Phase 2, we chose doses of 35 milligrams per kilogram and 50 milligrams per kilogram, and this is IV dosing every four weeks. We arrived at those doses as a consequence of the dose–exposure and some of the pharmacodynamic effects we observed in the Phase 1. So a combination of the Phase 1 results with some dose modeling allowed us to select these two 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 milligrams per kilogram 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 dataset, 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

Thank you. Our next question comes from Pete Stavropoulos with Cantor Fitzgerald. Your line is open.

Pete Stavropoulos (Analyst at Cantor Fitzgerald)

Good morning and congrats on the execution. Looking forward to the data next month and thanks for taking our questions. A couple for me. I’m wondering what your current thinking is in terms of the bar or what is the minimum you’d like to sort of see out of ALTITUDE 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 would we expect any OLE data in the readout?

Daniel O’Connell (Chief Executive Officer)

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 a placebo-controlled period. We think that’s a zone in which that would give us the basis for moving forward. In terms of the safety profile, the overall adverse event profile, including ARIA rates and infusion-site reactions and other elements of the safety profile, is going to be a part of this top-line readout.

We would anticipate low double-digit ARIA incidence and maybe consistent across the genotypes as part of the support of the oligomer hypothesis and the grounds on which sabirnetug would be moving forward to Phase 3. So that’s kind of how we’re thinking about that. So your second question, Pete—OLE data. So yeah, 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 will generate evidence into 2027 and likely won’t be part of the top-line results.

I think it’s 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 imaging, 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 p-tau217 as a measure of disease status, potentially progression.

And I think that’s going to be a complete dataset to inform stakeholders on the merits of sabirnetug and provide evidence in support of the oligomer hypothesis.

Pete Stavropoulos (Analyst at Cantor Fitzgerald)

All right, thank you for that. And just a question on EBD, how are you thinking about the path forward for 301 or 401—the SAD/MAD 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 in the MAD study? And what optionality do these candidates offer?

Daniel O’Connell (Chief Executive Officer)

Yeah, thanks, Pete. Well, yeah, 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 1 study exclusively in Alzheimer’s patients. That gave us really solid Phase 1 proof-of-mechanism data in support of sabirnetug, and that of course, as I just mentioned, informed dosing strategy and the plan for Phase 2.

I think the team’s 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 1, but through a robust Phase 2, that really serves as a foundation for our strategy for developing the EBD candidates.

Pete Stavropoulos (Analyst at Cantor Fitzgerald)

All right, thank you very much and congratulations on the progress once again.

Daniel O’Connell (Chief Executive Officer)

Thanks, Pete.

OPERATOR

Thank you. Our next question comes from Tom Schrader with BTIG. Your line is open.

Tom Schrader (Analyst at BTIG)

Good morning. 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 3 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? Thank you.

Daniel O’Connell (Chief Executive Officer)

Thanks, Tom. Good morning. So with sabirnetug’s high selectivity for toxic Aβ oligomers, 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, yeah, 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 interpretation of those results.

Tom Schrader (Analyst at BTIG)

Okay, fantastic. Good luck again.

Daniel O’Connell (Chief Executive Officer)

Thanks, Tom.

OPERATOR

Thank you. Our next question comes from Jeff Meacham with Citi. Your line is open.

Mary Cadom (Analyst at Citi)

Good morning. This is Mary Cadom for Jeff. Thanks for taking our question. 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 it address these needs? And then just as another one, maybe what feedback do they have on the mechanism here as well? Thank you.

Daniel O’Connell (Chief Executive Officer)

Great. So in our travels and interactions with KOLs, 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, 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, indirect fashion.

Mary Cadom (Analyst at Citi)

Great. Thank you.

OPERATOR

Thank you. Our next question comes from Dev Prasad with Lucid Capital Markets. Your line is open.

Dev Prasad (Analyst at Lucid Capital Markets)

Hi. Congrats on the progress and thank you for taking our question. 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 was chosen. Wondering, do you plan to initiate that work after the Phase 2 trial? Thank you.

Daniel O’Connell (Chief Executive Officer)

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. 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, not 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 blind to data. In respect to your question of 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 specifics I can offer on that question. And thirdly, in terms of the subcu, yes, we completed a healthy-volunteer essentially bioavailability study that read out in early ’25. We think we have what we need in terms of the contrast between IV dosing and subcutaneous dosing of the sabirnetug formulation. We anticipate using the Phase 3 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 3—that could be analogous to how we would be moving forward in the future with a subcutaneous option.

Dev Prasad (Analyst at Lucid Capital Markets)

Thank you.

OPERATOR

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

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