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5/16/2022
Thank you for standing by and welcome to the Acumen Pharmaceuticals first 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 a session, you will need to press star 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 first quarter 2022 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 action results to differ materially from those described in the forward-looking statements. Our action 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 review of select first quarter 2022 business highlights and provide an update on the ongoing Intercept-AD trial. Dr. Eric Siemers, Chief Medical Officer, will then discuss the recent Frontiers in Science article for ACU-193. Next, 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 first quarter and recent progress. We hosted our first public conference call in late March, and during that call we provided a review of our science, the significant differentiation of ACU193 for the potential treatment of Alzheimer's disease, and gave an overview of the ongoing Intercept-AD clinical trial. as well as highlighted our financial resources that are expected to advance ACU193 through multiple clinical milestones and provides a cash runway through 2025. Given that we provided such a detailed update just weeks ago, we're going to keep today's call relatively brief and to the point. To start, we continue to make significant progress with our Intercept-AD clinical trial of ACU193, the first monoclonal antibody developed to selectively target soluble amyloid beta oligomers to enter the clinic. Regarding enrollment, we have experienced continued success in activating new clinical trial sites and enrollment is now ongoing at 11 active sites with four additional sites selected for potential activation. This is up from eight active sites and six additional sites selected when we last spoke at the end of March. Given our progress, we continue to expect to report the top line results from Intercept AD in the first half of 2023. In parallel to conducting the Intercept AD trial, we've also made significant progress in preparing for a future Phase 2-3 trial of AC193. A chronic GLP toxicity study was initiated earlier in the year, and our new drug substance production process and drug product formulation are being finalized. Our team has begun designing the Phase 2-3 study and planning for an end of Phase 2 meeting with the FDA. Our plan is to initiate the next trial, a potential Phase 2-3 trial, rapidly after demonstrating proof of mechanism in the ongoing Intercept-AD trial. As I highlighted during our last call, we've made several senior-level appointments to the company's leadership team across multiple functional areas, and since then we've continued to grow our team, providing additional expertise and experience to support our expected growth over the coming years. In addition to our efforts, we do anticipate growing interest in upcoming clinical and regulatory developments for other novel Alzheimer's disease programs in the coming quarters. including Phase III data readouts for Esai's licanumab, Roche's scantinarumab, and Lilly's dinanumab. While these treatments are targeted primarily at amyloid plaques and protofibrils, not soluble A-beta oligomers, we believe encouraging data from one or more of these programs could lead to additional enthusiasm for ACE193 and its potential in Alzheimer's. I'll now turn the call over to Eric to discuss the recent publication in Frontiers in Neuroscience. Eric? Eric?
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