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11/12/2025
Good day, and welcome to the Acumen Farmer third 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. To ask a question, please press star 1-1. If your question hasn't been answered and you'd like to remove yourself from the queue, press star 1-1 again. As a reminder, this call may be recorded. I would now like to turn the call over to Alex Braun, head of investor relations. Please go ahead.
Thanks, Michelle. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended September 30th, 2025. With me today are Dan O'Connell, our Chief Executive Officer, and Matt Zuga, our CFO and Chief Business Officer. Matt and Dan have some brief prepared remarks, and then we'll open the call for questions. Joining for the Q&A session, we also have Dr. Jim Doherty, our 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 issue 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 issue this morning, and our most recent annual and quarterly reports, files of 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.
Great. Thanks, Alex. Good morning, everyone, and thank you for joining us today. In the third quarter, we continued our track record of operational execution on two fronts, the steady progression of our phase two altitude AD trial and the generation of additional nonclinical data supporting our enhanced brain delivery, or EBD, program. Our core hypothesis remains that synaptotoxic A-beta oligomers play a pivotal role in the development of Alzheimer's disease. and as such stand as a highly attractive therapeutic target for safe and efficacious treatment of AD. Altitude is investigating suburnatug, our humanitis monoclonal antibody, with high selectivity for A-beta oligomers. Suburnatug selectivity for toxic oligomers is central to why we believe it could unlock potentially greater clinical efficacy and improve safety relative to antibodies targeting amyloid plaque. We've made rapid progress in the substantial 18-month study Some of the 542 participants enrolled in the trial are already beginning to complete the placebo control phase, with the first participants scheduled to be dosed in the open-label extension as soon as today. In the open-label extension, all participants have the opportunity to receive Subirnatug at 35 milligrams per kilogram every four weeks for up to 52 weeks. The OLE represents not only our commitment to the participants involved in altitude, but will also provide us with valuable long-term safety and additional efficacy data to supplement the broader data package supporting Sobernatug. Based on our strong execution, we continue to expect top-line results for Altitude AD in late 2026, inclusive of the key efficacy and safety measures. For our EBD program, we recognized for some time that pairing a differentiated A-beta oligomer-directed cargo with a validated blood-brain barrier carrier technology could offer an attractive next-generation product opportunity in Alzheimer's. As you heard on our Q2 call in August, we announced a strategic collaboration, option, and license agreement with JCR Pharmaceuticals to develop an Alzheimer's disease product combining our A-beta oligomer-selective antibody expertise with JCR's transferrin receptor-targeting blood-brain barrier technology. As part of this effort, on the cargo or effector side of the construct, we are evaluating Sobernitug and other oligomer-selective antibodies from our library, including an antibody we're calling ACE234 that may have even greater selectivity for oligomers over monomers as compared with Sobernituk. For the carrier portion, we're exploring both single-chain and variable heavy domain antibody constructs from JCR's extensive TFR targeting libraries, which we consider cutting-edge approaches in the BBB space. The program is progressing nicely, and we expect to present varying data using some of our constructs at upcoming medical conferences. We continue to anticipate a non-clinical data package inclusive of a non-human primate study in early 2026, which will inform our decision to advance up to two development candidates under our exclusive option agreement with JCR. Finally, I would like to highlight the addition of Dr. George Golombeski to our board as chairman. With his addition, the board has increased to eight And George brings more than 30 years of experience in the biotechnology industry and is a highly recognized and experienced biopharma leader with a strong track record in business development, licensing, and strategic initiatives. His deep expertise aligns well with our current goals as we continue to advance our ongoing Phase II trial and EBD program to drive value for shareholders and Alzheimer's patients alike. And with that, I'll turn the call over to Matt for the financials.
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