Acumen Pharmaceuticals, Inc.

Good day. Thank you for standing by, and welcome to the Acumen Pharmaceuticals second quarter 2022 update call. At this time, all participants are in a listen-only mode. There will be a brief overview followed by a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. Today's call is being recorded, and I would now like to turn the call over to John Wolford from Westwick. Please go ahead.

Thank you, Operator. Good afternoon. Thank you for joining us today to review Acumen's second quarter 2020 update on operational progress and financial results. Before we start, we encourage you to read the operational and financial results press release issued this afternoon, which is accessible on our website in the Investors section. 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. All these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic, geopolitical events such as the conflict between Russia and Ukraine and related sanctions, and macroeconomic conditions such as rising inflation and uncertain credit and financial markets. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Acumen undertakes no obligation to update or revise any forward-looking statement. Dan O'Connell, President and Chief Executive Officer, will begin today's call with a review of select second quarter 2022 business highlights. Dr. Eric Siemers, Chief Medical Officer, will then discuss the recent developments in the Alzheimer's disease field and provide an update on the ongoing Intercept AD trial. Finally, Matt Zuga, Chief Financial Officer and Chief Business Officer, will provide a brief financial update. We will then open the call for Q&A. I'll now hand the call over to Dan O'Connell, President and Chief Executive Officer. Dan?

Thank you, John. Good afternoon, and thank you to everyone joining the call today. I'm delighted to be here to review our second quarter and provide a business update. Picking up from the momentum generated in early 2022, we continue to make progress with our Intercept-AD clinical trial of ACU193, the first monoclonal antibody developed to selectively target soluble A-beta oligomers to enter the clinic. Regarding site activation enrollment, we are continuing to activate new clinical trial sites. Intercept-AD enrollment is now ongoing at 15 active sites, up from 11 active sites as reported in our first quarter conference call in May, Given our continued progress in the trial, we believe we remain on track to report top-line results in the first half of 2023. In parallel to conducting the Intercept AD trial, we have also made progress in preparing for a future Phase 2-3 trial of ACU193. The chronic GLP toxicity study is ongoing, and we expect our new drug substance production process and drug product formulation should be finalized in the near term. The Phase 2-3 study design and planning for an end-of-Phase 2 meeting with the FDA are underway. Our plan is to be prepared to initiate the next trial, a potential Phase 2-3 trial, after the results of the ongoing Intercept-AD trial are available and assuming they demonstrate proof of mechanism. As I highlighted during our last call, we continue to grow the organization and make key additions to the senior leadership positions. Most recently, we have appointed Leanne Schenck as our VP Head of CMC, who brings to Acumen over 25 years of pharmaceutical industry experience in biologics process development, manufacturing, and CMC project management. Leanne started her career at Lonza Biologics before spending more than 20 years at Eli Lillian Company in various CMC roles. In her most recent position, she served as Head of CMC Program Management at Novavax. Since 2016, she has been responsible for CMC delivery of three commercial products in connections with these positions. Leanne is leading our CMC efforts, working closely with Kent Iverson, who continues to serve as a senior consultant on CMC matters. Ensuring timely and economical clinical drug products for potential late-phase development is a strategic imperative for Acumen, and we are confident in Leanne and her colleagues' abilities on this front. On a different note, I do want to acknowledge the departure of Dr. Jeff Sevigny, the Chief Medical Officer of Prevail Therapeutics, which recently became a wholly owned subsidiary of Eli Lillian Company. Jeff has recently stepped off our board as was required by his current employer. Jeff joined Acumen's board in 2019 and has been a major contributor. I want to thank Jeff for his service and support of Acumen over the last three years. He will be missed. Our nomination in Corporate Governance Committee has initiated a search for a potential new director. As many of you know, there are a number of anticipated upcoming clinical and regulatory developments for the novel Alzheimer's disease programs in the coming quarters, including Phase III data readouts for Esai's leucanumab, Roche's gantanarumab, and Lilly's dinanumab. Two weeks ago, Acumen and others attended the AAIC meeting in San Diego. The meeting served as an informative event to gauge the latest developments in the AD research field. On that note, I'll now turn the call over to Eric to discuss some of these recent developments from AEIC, including our poster on a potential standardized assay for evaluating soluble A-beta ligament binding properties for monoclonal antibodies. Eric?