Acumen Pharmaceuticals, Inc.

Good day and thank you for standing by. Welcome to the Acumen Pharma Q1 2023 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 during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Alex Braun, Head of Investor Relations.

Thanks, Jill. Good morning, and welcome to the Acumen Conference Call to discuss our business update and financial results for the quarter ended March 31st, 2023. With me today are Dan O'Connell, our Chief Executive Officer, Dr. Eric Seamers, our Chief Medical Officer, and Matt Zuga, our Chief Financial Officer and Chief Business Officer. Before we begin, we encourage listeners to go to the Investor section of the Acumen website to find a press release issued this morning and related slide presentation 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 2 of the accompanying 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 statement. 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. After our prepared remarks, we'll open the call for Q&A. I'll turn the call over to Dan.

Thanks, Alex. Good morning, and thank you, everyone, for joining us today. The first quarter of 2023 marked the completion of enrollment in our phase one intercept AD trial, evaluating AC193 in early Alzheimer's patients. The study is near completion with top-line results expected in the third quarter. For those of you who may be new to Acumen, our product candidate, AC193, is differentiated from other monoclonal antibodies studied in Alzheimer's disease based on its high selectivity for A-beta oligomers. Scientific consensus asserts that oligomers are the most toxic form of A-beta, and once they bind to neurons, they inhibit synaptic function and induce neurodegeneration. We are pleased that our top line results are positioned to provide important clinical proof of mechanism data for a monoclonal antibody developed to selectively target toxic A-beta oligomers in the effort to develop a next generation therapeutic for Alzheimer's patients. Intercept AD will provide valuable information required to finalize the design of our next phase for the program, including dose selection. At present, we have growing confidence that every four-week dosing is a viable scenario for ACU193. In addition, as previously disclosed, preliminary CSF PK data from cohort three, our 25 milligram per kilogram single ascending dose cohort, showed ACU193 concentrations substantially above reported levels of A-beta oligomers, indicating this may be a dosing option to include in our next study. We continue to prepare for phase 2-3 activities in anticipation of successful results from our phase 1 study. An end of phase 2 meeting with the FDA to discuss the design of the next trial is anticipated to be held in the fourth quarter. As previously disclosed, the study design incorporates an interim decision to expand the size of the study from a phase 2 to a phase three study, which is the most expeditious route to a BLA registration. We, along with the rest of the field, are encouraged by the positive momentum in the evolving Alzheimer's landscape. We are keen to see upcoming outcomes for Leucanumab's advisory committee meeting, PDUFA date, and any shift in CMS coverage decision, which would increase access and uptake for this therapeutic option for patients. We are also highly interested in digesting the full data set from the NANAMAB's Trailblazer 2 Phase 3 study announced last week. We recognize that robust plaque clearance has shown clinical benefit, albeit modest and with safety caveats. We believe there is potential better options for patients that involve selective targeting of toxic species more closely related to disease pathology, and that ACU193 embodies that product profile. We look forward to sharing our Intercept AD top line data with you in the third quarter of this year. a dataset that will be informative from a safety, target engagement, and dose ranging perspective. With that, I'll hand the call over to Dr. Siemers.