Acumen Pharmaceuticals, Inc.

Hello, and welcome to Acumen Pharmaceuticals Q3 2024 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 the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to hand the conference over to Alex Braun. You may begin.

Thanks, Tawanda. Good morning, and welcome to the Acumen Conference Call to discuss our business update and financial results for the quarter-ended September 30, 2024. With me today are Dan O'Connell, our CEO, and Matt Zuga, 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 a 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 meeting 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 development. So with that, I'll turn the call over to Dan.

Thanks, Alex. Good morning, everyone, and thanks for joining us today. The third quarter was one of focused execution as we continue to progress our clinical efforts for Subirnatug, our next-generation A-beta oligomer-targeted antibody for the treatment of early Alzheimer's disease. Altitude AD, our phase two study designed to evaluate the clinical efficacy and safety of subornatide in roughly 540 patients with mild cognitive impairment or mild dementia due to Alzheimer's, currently has more than 75 sites active and enrolling across North America, the UK, and the EU. Enrollment in Altitude has progressed faster than we expected, and we now anticipate completement of enrollment in the first half of 2025. We believe the altitude AD enrollment is due to characteristics stemming from Sobernatug's mechanism of action, along with enthusiasm from site investigators as bolstered by our robust phase one data. Furthermore, our team has done well to establish effective collaborations with top trial sites across all three regions. These factors have contributed to a promising enrollment rate and reinforced the interest in innovative treatment options and the therapeutic potential of Sobernatug. We have also continued to progress our phase one study of subcutaneous CBRNTUG and anticipate the top line results for this study will be available in the first quarter of 2025. Once we have the PK results in hand, we will be best positioned to formulate next steps for developing subcutaneous CBRNTUG. Moving on to our time at the CTAD meeting in Madrid, it was clear at the meeting that the Alzheimer's field is moving ahead on both the clinical and research fronts, particularly with anti-A-beta disease modifying treatments for AD. We see Acumen in a strong position to capitalize on this momentum. And I want to share a couple of key takeaways that underpin how the field is advancing into a new and exciting era. First, blood-based biomarkers were a frequent topic in multiple presentations during the meeting, including our own. Blood-based biomarkers are going to fundamentally enable new innovations in both clinical research and drug development settings. This impact is happening right now. Our presentation focused on data from our validated research-use plasma phospho-tau-217 assay, which we are using to screen potential participants in the ongoing Phase II altitude AD clinical trial. At CTAD, we reported that this p-tau-217 enrichment screening approach results in a higher proportion of patients who meet the amyloid PET or CSF-based inclusion criteria as compared to our Phase I intercept AD trial, which did not use this approach. Furthermore, the enrichment approach is resulting in a more efficient participant selection process that reduces unnecessary amyloid PET scans or lumbar puncture procedures among people who are not eligible to continue screening. Thus far in the study, it has reduced the screening incidence of negative amyloid PET scans by about 50% as compared to our Phase 1 study and contributed to the rapid enrollment. Second, the first reports of real-world use of Lekembe were presented from researchers from the U.S. and Japan, highlighting adoption protocols and the feasibility of treatment delivery in diverse geographies and populations. Though the currently marketed products have acknowledged limitations and are not for all patients, we support making them available for the right patients and under the management of the right clinical teams. Further, we believe the adoption of anti-A-beta treatments will continue to grow and ultimately serve as the cornerstone of AD treatment for the foreseeable future. In October, we hosted a virtual R&D day with members of the Acumen team and key opinion leaders in the Alzheimer's space. If you haven't had a chance to view the webcast, I encourage you to watch the replay that is available on our website. The event provides a deep dive into the scientific rationale supporting Sobernatug's mechanism of action, targeting toxic abate oligomers, our positive phase one clinical results, and the phase two clinical plans for Sobernatug. Additionally, shifting to the organization, just last week, we announced the appointment of Dr. Amy Shatterly as chief regulatory officer and head of quality. Amy brings to Acumen over 30 years of experience in regulatory affairs, quality assurance, and therapeutic development with a focus on CNS disorders. Given Amy's deep expertise and experience in global product development, we are thrilled to have her on board as we further refine our product development strategy ahead of key clinical data for Smyrna Tech. I'd also like to thank Dr. Janice Hitchcock, who led our regulatory affairs efforts amidst retiring at the end of the year. Janice has been instrumental in building our regulatory infrastructure, overseeing our regulatory strategy, And in driving Sobernatug into the clinic, we wish her the best in her retirement. At Acumen, we are focused on our strategic goal of advancing the clinical development of Sobernatug in a diligent and efficient manner. The recent developments in the Alzheimer's field, along with new data and a refined understanding of the disease, align with our scientific approach and development strategy. I look forward to providing updates as we progress towards phase two data and as we work to confirm Sobernatug's promise as a next generation treatment option with a strong benefit-to-risk profile. And with that, I'll turn the call over to Matt for the financials.