Acumen Pharmaceuticals, Inc.

Hello, and thank you for standing by. Welcome to Acumen Pharmaceuticals Q2 2024 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 the question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.

Thank you, Operator. Good morning and welcome to the Acumen Conference call to discuss our business update and financial results for the quarter ended June 30th, 2024. With me today are Dan O'Connell, our CEO, and Matt Zuga, our CFO and Chief Business Officer. Dan and Matt have some prepared remarks and then we'll open the call for questions. Joining for the Q&A session, we also have Dr. Jim Doherty, our President and Chief Development Officer, and Dr. Eric Siemers, our Chief Medical Officer. Before we begin, we encourage listeners to go to the Investors section of the Acumen website to find our press release issued this morning 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 our corporate 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. So with that, I'll turn the call over to Dan.

Thanks, Alex. Good morning, everyone, and thanks for joining us today. We've made significant progress in the first half of 2024 as we continue to execute our clinical plans for Subirnatug, our next-generation amyloid beta-ligamer-targeted antibody for the treatment of early Alzheimer's disease. AltitudeAD, our Phase II study designed to evaluate the clinical efficacy and safety of Subirnatug in patients with MCI or mild dementia due to AD, is actively enrolling. ALTITUDE-AD is a randomized, double-blind, placebo-controlled, three-arm study with approximately 180 participants per treatment arm for a total of 540 participants. ALTITUDE currently has more than 50 sites active across North America, the UK, and the EU, with the first subject dosed in May 2024. At present, enrollment in ALTITUDE is progressing faster than our original projections, which is highly encouraging. We attribute this to Sobernatug's distinct profile based on its mechanism of action and positive feedback and interest from investigators supported by our strong phase one data. Additionally, our team has built highly productive working relationships with quality trial sites in all three regions. These combined factors have translated into an encouraging enrollment rate and underpin the growing interest in novel treatment options for early AD and differentiated treatment potential of Sobernatug. In July, we also announced we had dosed our first subject in a phase one study of subcutaneous Subirnatug. The study will compare the pharmacokinetics between intravenous and subcutaneous administrations of Subirnatug in healthy volunteers. We view this work stream as an important extension of Subirnatug's product profile, which aims to offer flexibility and convenience in dosing for patients and caregivers. We anticipate the top-line results from this study will be available in the first quarter of 2025. Once we have the PK bioavailability results in hand, we will be best positioned to discuss next steps and clinical plans for subcutaneous suburnatide. Turning now to continued learnings from our clinical experience with suburnatide, the Acumen team recently presented further data analysis from the Intercept-AD trial at the Alzheimer's Association International Conference, or AAIC. Our team presented posters at this major Alzheimer's medical conference, detailing patient interviews, biomarker data supportive of Suburnatug's mechanism of action, and Acumen's ultra-sensitive method of measuring small amounts of Suburnatug in cerebral spinal fluid. The takeaways from our patient interviews underscore the importance of incorporating the patient voice into trial design and humanizing the unmet need in Alzheimer's disease. As expected, nearly all patients reported difficulty with memory and cognition, difficulty with getting lost, difficulty with communication, and changes in mood were also commonly reported. Almost 90% of patients would like a treatment to slow the progression of disease or keep it from getting worse, as well as maintain the ability to recognize loved ones. We also received strong interest in the synaptic biomarker changes observed in our phase one study. Both pre- and post-synaptic cerebrospinal fluid proteins, VAMP2 and neurogranin, showed significant reduction towards normalization, which is consistent with Sobernafug's ability to inhibit amyloid beta-oligomer synaptic binding. These posters can be found on the investor section of our website if you haven't already had a chance to review them. As usual, there was a great deal of interesting information shared at AEIC, including a number of topics relevant to our subvertotype program. These topics included the continued development of fluid biomarkers like pTau217 as diagnostics for tracking the progression of Alzheimer's, further data on the important role that soluble amyloid data species play in the pathophysiology of AD, and extended safety and efficacy data on chronic dosing with anti-amyloid monoclonal antibody therapies. We believe the increased acceptance of the toxicity and persistence of soluble amyloid beta species, such as oligomers, will help move the field towards next-generation antibodies, such as the Bernadote, and the confluence of fluid biomarker breakthroughs will support expanded future access to novel treatments in AD. Finally, we are planning to host a virtual R&D day on October 2nd. We intend for this event to provide a deep dive into the scientific rationale supporting Sobernatug's mechanism of action, our phase one clinical results, and phase two clinical plans for Sobernatug. We will communicate the registration details and agenda closer to the event. We remain committed to delivering on our strategic priority to efficiently and thoughtfully advance the clinical development of Sobernatug and are encouraged by the direction the Alzheimer's field is headed with new data and an updated understanding of the disease that is in line with our science. I look forward to updating you as we work towards phase two data that we believe will provide a significant value inflection for the program and demonstrate Subirnatug's true potential as a next gen treatment with a highly compelling benefit to risk profile. And with that, I'll turn the call over to Matt for the financials.