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10/26/2026
Good day and welcome to the Acumen Pharmaceuticals third quarter 2026 conference call and webcast. At this time, all participants are in a 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 1-1 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.
Thanks, Michelle. Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended September 30th, 2026. With me today are Daniel 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 Investor 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 their 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.
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 two Altitude AD trial, investigating our lead product candidate, Sobernitog. 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. AltitudeAD is a large, well-powered Phase II trial with clinically meaningful endpoints. We are testing two doses of Subirnatug 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 III anticipated following positive Phase II results. As previously outlined, AltitudeAD was designed to detect a statistically significant difference between suburnatug and placebo on the primary efficacy endpoint, Idris, 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 Suburnatug 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 two candidates in the lead-up to an IND filing expected in mid-2027. One candidate, ACU301, is based on a bispecific antibody incorporating suburnatone, and ACU401 incorporates a novel A-beta-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 multi-fold 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 we observed in the cinnamolus 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 Subbernative 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.
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