Acumen Pharmaceuticals, Inc.

Thank you for standing by, and welcome to the Acumen Pharmaceuticals second quarter 2023 update call. At this time, all participants are in a listening mode. There will be a brief overview followed by a question and answer session. If you would like to ask a question, please press star 11 on your telephone, and you will hear an automated message advising your hand has been raised. If you would like to take yourself out of the queue, please press star 11 again. Today's call is being recorded, and I would now like to turn the call over to Alex Brunn, Head of Investor Relations. Please go ahead.

Thank you, Lisa. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended June 30th, 2023. 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 investor section of the Acumen website to find our press release issued this morning and related slide presentation 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 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 statements. 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. Now, I'll turn the call over to Dan.

Thanks, Alex. Good morning, and thanks to everyone who has joined us today. A few weeks ago, Acumen presented compelling clinical data in support of ACU193, our asset for the treatment of early Alzheimer's disease. Our positive phase one top-line results solidify ACU193's potential as a future option in the Alzheimer's treatment paradigm. The success of our novel target engagement assay, robust study design, and committed execution enabled us to demonstrate convincing proof of mechanism inclusive of significant amyloid plaque reduction. ACU193 was shown to be safe with a broad therapeutic index and with attractive dosing options for our next phase of development. We believe these results substantially de-risk our asset beyond our expectations at this stage in its clinical development. I'm extremely proud of our team's achievement and would like to thank our employees, site investigators and staff, and patients and caregivers for their dedication to advance AC-193 as a potential best-in-class treatment in this important field. If you have not already done so, I encourage you to go to the investor section of our website and view the webcast from July 17th with our full presentation of the Intercept-AD phase one top line results. Moving forward, we are firmly committed to harnessing the optionality provided by the phase one data set. We have a knowledgeable and adept clinical regulatory and CMC team at Acumen with significant large pharma experience in Alzheimer's drug development. Given the positive intercept AD trial data, including the observed rapid plaque reduction by AC193, our team is working urgently to integrate the findings into both our future clinical plans and our broader strategic priorities. We continue to analyze the data from this study and expect further biomarker data to be available in the fourth quarter. We are also finalizing our doses for our next clinical trial, which Eric will discuss. We have made modest changes to our planned Phase 2-3 design, given AC193's ability to rapidly reduce plaque, such as incorporating amyloid PET into interim analyses. As previously disclosed, our Phase 2-3 design incorporates interim analyses to inform the potential of expanding the size of the study from a Phase 2 to a Phase 3 study, which we believe is the most expeditious route to a BLA filing and potential approval. We continue to anticipate an end of Phase 2 meeting with the FDA to discuss this Phase 2-3 design in the fourth quarter. As mentioned on our July 17th call, we are investigating the viability of subcutaneous dosing of ACU193 as we recognize the potential attractiveness of this mode of administration to expand patient dosing options. We have made meaningful progress on this front and aim to have more details to share later this year. I should also comment that we are continuously evaluating strategic partnerships and are committed to exploring value enhancing opportunities that advance AC193's development and align with Acumen shareholders' interests. Before I turn the call over to Eric, I would like to emphasize the degree to which our phase one results have elevated AC193's profile in the field. We believe AC193's high selectivity to bind to toxic soluble A-beta oligomers in the brain, confirmed by our CSF target engagement assay, affords it the potential to differentiate in terms of clinical efficacy. AC193's ability to significantly reduce plaque in only three months, in line with currently approved and under review anti-A-beta antibodies, we believe further de-risks the asset's potential to deliver efficacy. Monthly dosing provides another important point of differentiation. We intend to drive significant momentum from these timely results and look forward to sharing our progress with you as we execute against our operational and strategic priorities in the weeks and months ahead. With that, I'll hand the call over to Dr. Siemers. Eric?