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8/12/2026
Good day and welcome to the Acumen Pharmaceuticals second 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 1-1 on your touchtone telephone. Please note this call is being recorded. I would now 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 June 30th, 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. Please see slide two 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.
Great. Thanks, Alex. Good morning, everyone, and thanks for joining us today. During the second quarter, our focus remained on discipline execution as we advanced Subronatug 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 A.D. 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 support this hypothesis, and we are excited by the opportunity to evaluate that thesis in a well-powered randomized phase two study with clinically meaningful endpoints our phase two results have the potential to substantially expand on our phase one results, which included demonstration of A-beta-oligomer target engagement and biomarker changes that were seen as early as three 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 reflection 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've previously described, Altitude AD was designed to detect a statistically significant difference on its primary clinical efficacy endpoint, the IDRIS, after 18 months of treatment with Sobernatum, compared with placebo. We expect the top-line data set 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 milligrams per kilogram and 50 milligrams per kilogram, 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 Sorenatog 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 ACU-301 and ACU-401. ACU-301 is a bispecific antibody incorporating subernatide and ACU-401 incorporates a novel next-generation abetoligomer-selected antibody with differentiated properties. This is known as ACU-234. 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 most 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 achieved 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 cinnamologous monkeys combined with preserved soluble A-beta oligomer selectivity in 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 16th. 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 Day 2 Data Rehab. The advance of Suburban Tug in 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 EBD program and on our Phase 2 results for Zubarna Tug late this year. And with that, I'll turn the call over to Matt.
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