3/26/2026

speaker
Michelle
Conference Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Acumen Farmer fourth quarter 2025 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. And to ask a question during the session, you would need to press star 11 on your telephone. You will then hear an automated message of us and your hand is raised. And to withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Alex Ron, head of investor relations. Please go ahead.

speaker
Alex Ron
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 year ended December 31st, 2025. With me today are Dan O'Connell, our Chief Executive Officer, Dr. Jim Doherty, our President and Chief Development Officer, and Matt Suga, our CFO and Chief Business Officer. They will have brief 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. 2025 can be defined as a year of execution and expansion at Acumen. We made demonstrable clinical progress for our lead program, Sobernatug, in our Phase II altitude AD trial, which we consider an important test of our core hypothesis that synaptotoxic amyloid beta oligomers play a pivotal role in the development and progression of Alzheimer's disease. Altitude is a well-powered Phase II study that is investigating Sobernatug, our monoclonal antibody, with high selectivity for A-beta oligomers. Suburitug selectivity for toxic oligomers is central to why we believe it could unlock potentially greater clinical efficacy and improved safety relative to amyloid plaque-directed antibodies. We are closely tracking the plan with Altitude. We completed enrollment about a year ago, and the participant transition into the 12-month open-label study that started last November continues to be smooth and with a high rate of conversion. In 2025, we also expanded our pipeline in our persistent pursuit of innovation, which aligns with our mission of improved treatment options for people impacted by Alzheimer's. Our enhanced brain delivery, or EBD, partnership with JCR Pharmaceuticals, which combines Atkins A-beta oligomer targeted therapeutic cargo with JCR's validated blood-brain barrier carrier technology, holds potential to produce a truly next-generation differentiated therapy for Alzheimer's disease. We think of EBD as supercharging our antibodies to significantly increase brain penetration and distribution with potentially lower safety risks and in a convenient subcutaneous dosing format. We believe our EBD approach is well-suited for study in a preclinical or pre-symptomatic AD population. And though not contemplated in our immediate clinical development plans, we foresee that population as an attractive opportunity for the future. 2026 is poised to be a transformative year for Acumen. We expect to read out altitude AD late this year, inclusive of key clinical efficacy and safety measures. We believe the study results will inform our development strategy in the field more generally in terms of better understanding of the impact of clearing A-beta oligomers in Alzheimer's patients. Our optimism for the success of altitude is based in part on imaging and fluid biomarker data from our phase 1b intercept AD study. For instance, after just three doses, at the final three-month time point, Subirnatug showed positive effects on phosphatidyl-181 and neurogranin levels in CSF. These are competitive indicators in the AD space and continue to gain acceptance as diagnostic and clinical markers of disease. We view these data as supportive of Subirnatug's potential in phase two, which assesses safety and efficacy of Subirnatug over 18 months of treatment. We're obviously very excited to see these data later this year. Our EBD program is also gaining momentum. Just last week, we announced preclinical data, including in vitro, in vivo, and non-human primate study results that support multiple potential development candidates in the program. Jim will speak more about these results in just a minute. Importantly, the candidate profiles achieved exceeded our target product profile for the EBD program and catalyzed a roughly $36 million private placement. As of now, we are targeting the filing of an IND for a clinical candidate in mid-27. A final note on the sentiment in the AD field. We just returned from the ADPD conference in Denmark, where the energy and momentum in the Alzheimer's space was palpable. Between real-world data supporting the currently marketed therapies, the growing evidence that targeting A-beta is clinically beneficial, as well as the adoption of blood-based biomarkers to streamline development, diagnosis, and treatment, this is a hopeful time for Alzheimer's patients and their families. It's also important to realize we're still in the beginning of the treatment evolution in AD, and ample opportunity exists to provide improved benefit-risk options for patients. Between Suburnatug's Altitude AD results and our Next Generation EBD program advancing this year, we at Acumen believe our commitment to scientific innovation and track record of execution will enable us to deliver differentiated treatment options for Alzheimer's patients. And with that, I'll turn the call over to Jim.

Disclaimer

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