Acumen Pharmaceuticals, Inc.

Good day and welcome to the Acumen Pharma fiscal year 2024 conference call and webcast. At this time, all participants are in a listen-only mode. After this presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, 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 year ended December 31st, 2024. With me today are Dan O'Connell, our CEO, and Matt Zuga, our CFO and Chief Business Officer. Matt and Dan 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 for development. So with that, I'll turn the call over to Dan.

Thanks, Alex. Good morning, everyone, and thanks for joining us today. ICUMEN entered 2024 from a position of strength, stemming from our positive results for Sobernatug in our Intercept-AD Phase I study in early Alzheimer's patients. In Intercept-AD, Sobernatug was well-tolerated, demonstrated novel target engagement of A-beta oligomers, and produced consistent effects on imaging and fluid biomarkers in a dose-dependent manner. I'm proud, though not surprised, that our talented team leaned into this momentum and executed on our enrollment plans for Altitude AD, our phase two study designed to evaluate the clinical efficacy and safety of Sobernatug in patients with MCI or mild dementia due to Alzheimer's, also known as early AD. Last year, our team worked effectively to advance the Sobernatug story, and we believe this underpinned the swift pace of enrollment seen in Altitude. We engaged with the research community who recognized and embraced the novelty of Sobernatug's mechanism of action targeting toxic A-beta oligomers. We also engaged with experienced clinical investigators and trial sites who appreciate the consistency of the Phase I results with this mechanism and who also recognize Sobernatug's potential as a next-generation treatment for early AD based on an improved benefit-to-risk profile. We dosed the first patient in altitude in May of 2024, and just yesterday announced the completion of enrollment of 542 participants in the study. This clinical enrollment milestone is a key catalyst for our CBRNTUG program. This accomplishment also provides convincing evidence of our team's ability to operationalize and exceed enrollment goals for this sizable multinational phase two trial. The study's primary endpoint is a change from baseline to 18 months on the integrated Alzheimer's disease rating scale, or IDRIS, which measures cognition and activities of daily living, such as performing common household tasks, engaging in hobbies, and conversing about current events. We've also incorporated the CDR sum up boxes and other typically used secondary measures, including imaging and fluid biomarkers. With enrollment now complete, we expect top-line results in late 2026, inclusive of the key efficacy and safety measures. We also recently completed our phase one study investigating a subcutaneous administration of Suburnatug. This was a pharmacokinetic comparison study comparing subcutaneous and intravenous administrations of Suburnatug in healthy volunteers. We believe a potential subcutaneous formulation of Suburnatug alongside the IV formulation will create important optionality for patients and providers. For instance, in some cases, greater convenience via subcutaneous administration may be more important and advantageous, whereas more touchpoints provided by IV infusions may be more appropriate or preferred in other situations. Providing Subirnatug in both formats may also facilitate greater optionality around treatment and induction, excuse me, treatment induction and maintenance phases. Importantly, results from the study showed that subcutaneous subvernitug was well tolerated, with systemic exposure supporting the continued development of this format. Our next steps for the development of subcutaneous formulation of subvernitug will include ongoing formulation work and other data inputs. We remain committed to communicating the development of subvernitug through presentations at medical conferences and peer-reviewed publications. We've maintained a significant presence at all the major Alzheimer's conferences, ADPD, AAN, AAIC, and CTAD, we will present our Phase I results at several upcoming medical meetings. These presentations will focus on the importance of our fluid biomarker data that showed consistent trends towards normalization after only three doses in the study. I am very pleased to note as well that our Intercept AD Phase I manuscript was published in the Journal of the Prevention of Alzheimer's Disease, or JPAD, in January 2025. In addition, a related publication detailing the fluid biomarker changes in that study was also published online in J-PAD just last month. You can find both publications online at the journal and linked on our website. Next week at ADPD, we will also present the use of a plasma PCOW217 assay as a screening procedure in altitude AD, our ongoing phase two study. The use of this screening assay considerably improved enrollment efficiency and decreased patient burden and cost in the screening process. Feedback on the use of this PTAL 217 assay has been very positive, as evidenced by the rapid pace of our Phase II enrollment. Utilization of fluid biomarkers in this way is a prime example of innovation in the Alzheimer's space and a clear indication of how fluid biomarkers will continue to advance the field from diagnostic, treatment, and development perspectives. At Acumen, we are staunchly committed to our strategic goal of advancing the clinical development of Subarnatug in a diligent and efficient manner. We are executing at a very high level as supported by all of the progress reported here today. We remain encouraged by the continued adoption of new Alzheimer's treatments, which we believe illustrates the large underlying demand in this growing and long underserved patient population. The fundamental elements of the Alzheimer's landscape include an aging population, more diagnosed cases driven by the increasing ability to diagnose in earlier stages of disease due to better blood-based biomarkers, and more treated cases due to the availability of options and continued establishment of screening and infusion capabilities for monoclonal antibodies. 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. The dynamics of this patient population also present a great opportunity for improvements with next-generation anti-amyloid therapies, and in the future, combination approaches. We believe in the promises of Bernatug as a next-generation treatment option for Alzheimer's patients based on an improved benefits-risk profile and are highly motivated to make an outsized impact on this devastating disease, which affects all of us in one way or another. I look forward to providing updates as we progress towards the Altitude AD Phase 2 data readout next year, and with that, I'll turn the call over to Matt for the financials.