Acumen Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the Acumen Pharma Q3 2022 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. 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. Please begin.

Thank you, Latonya. Good afternoon and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended September 30th, 2022. With me today are Dan O'Connell, our Chief Executive Officer, Dr. Eric Siemers, 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 Investors section of the Acumen website to find our press release issued this afternoon and 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 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 the accompanying presentation Our press release issued this afternoon 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 any 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. Now I'll turn the call over to Dan.

Thank you, Alex. Good afternoon, and thank you for joining our call today. The third quarter was characterized by increased momentum on several fronts for Acumen. The highlights include improved enrollment in the ongoing Intercept-AD trial, fast-track designation for ACU193 from the FDA, and publication of our Intercept-AD trial design and anticipated critical development plan for ACU193. I'd also like to note that our progress comes amid renewed optimism in the Alzheimer's field due to Leucanumab's recent positive clinical trial results, which reinforce the role that soluble A-beta species may play in the disease. I'll start today by discussing our business and operational highlights, and Dr. Siemers will then provide some comments and context on the recent developments for both ACU193 and the Alzheimer's field as a whole. Turning to updates from our Phase I Intercept AD clinical trial of ACU193, the first monoclonal antibody discovered and developed to selectively target soluble A-beta oligomers to enter the clinic. Enrollment is now ongoing at 17 active sites in the U.S. As previously noted during the initial stages of the trial last year, in early 2022, we experienced slightly slower patient enrollment than originally projected. However, in the last four months, patient recruitment and enrollment has accelerated considerably. We are working closely with our partner CRO and clinical sites to ensure timely scheduling of the various visits per the study protocol, which also include imaging conducted at third-party sites. We are pleased that enrollment method is accelerating ahead of the holiday season. I should also note we are very encouraged with the safety profile observed to date in the trial, which aligns with our expectations for ACU193. Based on the trial current status, we are targeting enrollment completion in the first quarter of 2023 and reporting top line results in the second half of the year. In anticipation of moving quickly to a subsequent clinical trial, I want to provide an update on some of the pertinent Phase 2-3 activities that have been completed or are underway. On the toxicology front, the in-life phase of the chronic GLP toxicity study has been successfully completed and the final study report is expected in the first quarter of 2023. Our chemistry manufacturing and controls team, led by Leanne Shank, who joined as head of CMC this June, is working diligently to ensure clinical drug readiness in support of the planned Phase 2-3 study for AC193. We have completed development of our new drug substance production process and produced our first Phase 2-3 drug substance manufacturing lot, We have also completed development of the lyophilized formulation of our drug product. Based on this progress, we are well positioned to scale manufacturing and have sufficient drug supply to meet the requirements of our current development plan. As part of these CMC efforts in our application for the non-proprietary name for ACU193, we have confirmed ACU193 as a consensus IgG2 subclass antibody, which is consistent with our hypothesis that the reduced effector function of this subclass should favorably influence safety outcomes for AC193. We continue to pay close attention to the development of subcutaneous formulations of other antibody products in the Alzheimer's field. Dependent on observed patient dosing information generated in our phase one study, we will assess options for potential development of subcutaneous formulation as part of our AC193 product development plans. Though we were acutely focused on advancing Intercept AD and readying for the next phase of our development plan for the product, we do continuously evaluate the landscape for opportunities that fit with our capabilities and expertise. We are committed to being highly selective in the deployment of capital and evaluating such opportunities, but also appreciate that pipeline expansion could be a path to greater value creation in the future. On a final note, during the third quarter, we continue to expand our senior leadership team adding Derek Meissner as chief legal officer. Derek's legal career has spanned more than two decades at both biotechnology companies and investment firms, and he's a valuable addition to the company and our senior leadership team. With that, I'll hand the call over to Dr. Eric Siemers. Eric?