Acumen Pharmaceuticals, Inc.

Thank you for standing by and welcome to the Acumen Pharmaceuticals fourth quarter and full year 2021 update call. At this time, all participants are in a listen-only mode. There will be a presentation followed by a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. If you require any further assistance, please press star 0. Today's call is being recorded, and I would now like to turn the call over to John Wolford from Westwood. Please go ahead.

Thank you, Operator. Good afternoon. Thank you for joining us today to review Acumen's fourth quarter and full year 2021 operational progress and financial results. Before we start, we encourage you to view the slides for this webcast, as well as the operational and financial results press release issued this afternoon, both of which are accessible on our website in the investors section. As shown on slide two, 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 and the timing and extent of recovery from it. 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 high-level overview of Acumen and review select 2021 business highlights. Dr. Eric Siemers, Chief Medical Officer, will then provide a quick primer on amyloid beta oligomers and discuss the ongoing Intercept AD trial. Next, Matt Zuga, Chief Financial 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.

Thank you, John. Good afternoon, and thank you to everyone joining the call today. I'm delighted to be here on our first conference call as a public company. Moving to slide three, 2021 was a transformational year for Acumen, highlighted by the achievement of several major accomplishments, including our successful IPO. As this is our first public call, I want to take a moment to provide a brief introduction to Acumen for those that may be new to the company. Acumen is focused on the development of novel targeted therapeutics for Alzheimer's disease, which has received significant attention over the last year given the approval and launch of Biogen's Adderhelm. While controversial, the Adderhelm approval has brought substantial and needed attention to the enormous need to help people living with Alzheimer's disease. While many companies have pursued treatments targeted to amyloid plaques, fibrils, or monomers, Acumen has focused on targeting amyloid beta oligomers. We believe there is an emerging scientific consensus that oligomers are the most toxic form of amyloid beta, and that the development of a product that reduces toxicity of oligomers is one of the most promising approaches for the potential treatment and prevention of the progression of Alzheimer's. Our lead product is ACU193, the first monoclonal antibody developed to selectively target amyloid beta-oligomers to enter clinical testing. ACU193's potential is supported by extensive preclinical data supporting its differentiation from other anti-amyloid programs. To guide ACU193's development, we have assembled an experienced leadership team with significant industry expertise in Alzheimer's drug discovery and development. Many of our employees were formerly part of Eli Lilly's Alzheimer's team. As I mentioned earlier, we successfully completed an IPO in 2021. We raised approximately $184 million in gross proceeds in the offering that included multiple well-respected biotech investors and provides us the financial resources to advance AC193 through multiple clinical milestones and extending our cash runway through 2025. The next key milestone for ACU193 is proof of mechanism data from our ongoing phase one trial in early Alzheimer's disease, which is now expected in the first half of 2023. Eric will discuss the trial shortly. I'll now move to some key business highlights in 2021, as shown on slide four. Following the funding of a $30 million tranche from a Series B financing in June, We rapidly strengthened our balance sheet further with the completion of our IPO, raising gross proceeds of $184 million, as I mentioned. We then initiated the Intercept AD trial, dosing the first patient in October. We were then pleased to be accepted to present at the 2021 Clinical Trials on Alzheimer's Disease, or CTAD, conference in November in Boston. At the conference, we discussed the scientific rationale for targeting amyloid beta-oligomers the clinical trial design of Intercept-AD, and how the study is designed to establish safety and proof of mechanism and assess any potential improvements in cognition and blood flow in the brain. To support our expected growth over the coming years, we recently made several senior-level appointments to the company's leadership team. The new leaders include Julie Bakken-Steady, Head of Human Relations, Suteen Ghan, Head of Clinical Operations, and Stephen Reynolds. corporate controller, and treasurer. All three bring deep experience and collective passion for improving the lives of patients with Alzheimer's disease. I'd also like to use this opportunity to welcome Kim Drapekin to our Board of Directors, effective April 1st. Ms. Drapekin brings to Jounce more than 20 years of experience working with private and publicly traded biotechnology and pharmaceutical companies, including building and leading finance functions, raising capital, and leading strategic financial planning. Turning to slide five, we continue to make significant progress in advancing the Intercept AD trial. As I mentioned previously, we now expect to report top line results in the first half of 2023, a slight revision from our previous timing of year end 22. We believe the COVID-19 pandemic impacted our site activation timeline and enrollment somewhat. However, given our strong financial position, we also now plan to incorporate a larger data set expanded to the end of study and database lock. Regarding enrollment, we have experienced continued success in activating clinical trial sites, and enrollment is now ongoing at eight active sites with six additional sites selected for potential activation. Time to activation of these sites has accelerated dramatically starting in 2022. In parallel to conducting the Intercept AD trial, we have also made significant progress in preparing for a future Phase 2-3 trial of AC193. Chronic GLP toxicity testing has been initiated and our new drug substance production process and drug product formulation are being finalized. We have begun designing the Phase 2-3 study and planning for an end of Phase 2 meeting with the FDA. Given this headway, we anticipate being able to initiate the next trial rapidly after demonstrating proof of mechanism in the Intercept-AD trial. I'll now turn the call over to Dr. Eric Siemers, our chief medical officer.