Acumen Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Acumen Pharmaceuticals Q1 2025 conference call and webcast. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. I would now like to hand the conference over to your speaker today, Alex Braun, Head of Investor Relations.

Thanks, Josh. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended March 31st, 2025. With me today are Dan O'Connell, our CEO, and Matt Suga, our CFO and Chief Business Officer. Dan and Matt have some 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. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. 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. As we noted in our year-end call in late March, Acumen continues to build momentum towards our goal of establishing Suburnatug as a next-generation treatment option for patients with mild cognitive impairment or mild dementia, known as early Alzheimer's disease or early AD. In the first quarter, we completed enrollment of our 542 participant phase two study, Altitude AD, which is designed to evaluate the clinical efficacy and safety of Suburna Tugging patients with early AD. We completed enrollment of Altitude in roughly 10 months, much faster than expected. We attribute the rapid pace of enrollment to the interest Subirnatug's therapeutic potential, as supported by an extensive non-clinical data set and positive phase one results, innovative participant screening methods used in the trial, and strong execution by our team and clinical partners. We expect top-line results for Altitude AD in late 2026, inclusive of the key efficacy and safety measures. In April, we presented at two major Alzheimer's medical conferences, ADPD and AAN, Consistent with the rapidly growing focus on the utility of fluid biomarkers in AD, our presentations highlighted an innovative use of a plasma phospho tau 217 screening procedure in altitude AD. Our study, combined with multiple recent clinical investigations, support the use of plasma p tau 217 as a sensitive indicator of the presence of amyloid pathology. Our objective for the PTAL217 screening was to reduce the number of negative PET scans, thereby streamlining the screening process. In our Intercept Phase 1 study, only 40% of individuals screened for participation in the study tested positive on amyloid PET. In comparison, by screening for a specific threshold of PTAL217 in altitude prior to a PET scan, 81% of screened individuals that met or exceeded the threshold tested positive on amyloid PET, a significant improvement. The use of the PTAL 217 screening assay improved enrollment efficiency, decreased patient burden, and reduced screening costs in altitude. We believe this approach contributed to our very rapid enrollment rate and serves as a clear example of how we consistently implement innovative approaches to AD drug development based on insights and emerging data from the field. Building off the intercept manuscript and biomarker changes that published in Q1 in the Journal for the Prevention of Alzheimer's Disease, at ADPD and AAN, we also presented posters detailing other innovations our team has made to deepen the conversation around suburnatug's therapeutic potential. These innovations include insights into the early effects of suburnatug on synaptic biomarkers in AD, methods to develop A-beta-oligomer selective assays, and a non-clinical model to test more precisely the interactions between Sobernatug and A-beta oligomers that better replicates the human brain environment. Methods posters like these are important, as they align with our view that A-beta oligomers are the most toxic form of amyloid in the Alzheimer's brain, and thus advancements to such assays and tools can help inform oligomer preference of selective drugs like Sobernatug. As communicated on our year-end call, during the first quarter, we also completed a phase one study investigating a subcutaneous administration of Suburnatug, comparing subcutaneous and intravenous administrations of Suburnatug in healthy volunteers. Importantly, results from the study showed that Suburnatug was well-tolerated with systemic exposure supporting the continued development of this route of administration. Our next steps for the development of Sobernatug for subcutaneous administration involve ongoing formulation and drug delivery assessments. We are confident in Sobernatug as an innovative and differentiated potential treatment for people with Alzheimer's disease. Our team is driven each day by the opportunity to make a difference in the fight against this devastating disease. We continue to execute to establish Sobernatug's therapeutic potential and are excited to be on track to share the phase two results late next year. And with that, I'll turn the call over for Matt for the financials.