8/12/2025

speaker
Michelle
Operator

Good day and welcome to the Acumen Pharmaceuticals second quarter 2025 conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question at that time, please press star 1-1. As a reminder, this call may be recorded. I would like to turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.

speaker
Alex Braun
Head of Investor Relations

Thanks, Michelle. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended June 30th, 2025. With me today are Dan O'Connell, our Chief Executive Officer, Dr. Jim Doherty, our Chief Development Officer, and Matt Buga, 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. 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. And with that, I'll turn the call over to Dan.

speaker
Dan O'Connell
Chief Executive Officer

Great. Thanks, Alex. Good morning, everyone, and thanks for joining us today. I have a few remarks to make before handing the call over to Jim to provide some details about our recently announced Enhanced Brain Delivery, or EBD, program. Then Matt will detail our quarterly financial results before we open the call for questions. Second quarter was a productive one for Acumen, marked by steady operational progress and an important strategic partnership to expand our portfolio. Following the rapid completion of enrollment in our phase two altitude AD study in the first quarter, we continue to make great progress with the study. At the recent AAIC conference in Toronto, we received positive feedback from site investigators about the study design, patient retention, and our team's engagement. Based on this strong execution, we continue to expect top line results in late 2026, inclusive of the key efficacy and safety measures. Altitude is investigating sivernitug, our monoclonal antibody with high selectivity for toxic A-beta oligomers. This selectivity is key to why we believe sivernitug could unlock potentially greater clinical efficacy and improved safety relative to antibodies targeting amyloid plaques. At AAIC, we also presented data showing sivernitug achieved the highest selectivity for A-beta oligomers over monomeric A-beta when compared to recombinant leucanumab and aducanumab. The reason why this is important is that A-beta monomer levels are approximately 7,000-fold higher than the low-abundance toxic oligomer levels found in the diseased Alzheimer's brain. So lower affinity for monomeric A-beta, what Subiratuk demonstrates, is going to increase functional selectivity because less of the antibody will be binding to monomer. I'd also like to mention that we are encouraged by the recent comments from commercial players in the space, highlighting the growth of the clinical infrastructure for diagnosis Alzheimer's disease. Feedback from KOLs and others in the field also have noted greater easing of clinical bottlenecks. Real-world long-term data from the currently marketed products reported at AAIC demonstrate the clinical benefit of these products growing over time, further supporting their adoption. In addition, the first blood-based biomarker has been approved by the FDA, and others are being developed. We believe blood-based biomarkers will revolutionize the field by making an accurate and potentially earlier diagnosis much more efficient. We also believe they will help expand the demand for anti-amyloid treatments. It's terrific to see the field moving forward and the clinical infrastructure coming online, as well as the increased blood-based diagnostic options for the benefit of patients and their families. This momentum, we believe, sets the stage for Subirnatug and potential next-generation EBD products in the future. as there remains a very significant untreated patient population interested in receiving anti-amyloid therapy. We're excited about the potential of CERVERNATOG to provide a differentiated benefit-to-risk treatment option for patients and the future possibility of building on that with an EBD product or products. Moving to EBD, in July, we announced a strategic collaboration option and license agreement with JCR Pharmaceuticals based in Japan. This collaboration is to develop an Alzheimer's disease product combining our A-beta oligomer-selective antibody expertise with JCR's transferrin receptor-targeting blood-brain barrier-penetrating technology. We chose to partner with JCR as they are an established leader in the BBB space. Importantly, the partnership extends our portfolio and builds on our confidence in the potential treatment benefit of targeting toxic A-beta oligomers. We've been working closely with JCR for more than a year, and I'm very excited at the potential to develop a differentiated next generation treatment option for patients and shareholders alike. We expect to make a development decision for up to two product candidates in early 2026 based on non-clinical data. I'll now turn the call over to Jim to expand on our progress and our EVD strategy.

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