5/12/2026

speaker
Didi
Conference Operator

Good day and thank you for standing by. Welcome to the Acumen Pharma first quarter 2026 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 during the 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. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Alex Braun, Head of Investor Relations. Please go ahead.

speaker
Alex Braun
Head of Investor Relations

Thanks, Didi. Good morning and welcome to the Acumen Conference Call to discuss our business update and financial results for the quarter ended March 31st, 2026. With me today are Dan O'Connell, our Chief Executive Officer, and Matt Zuga, 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. 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. 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. 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 ended last quarter's call by emphasizing the progress we've achieved with Subirnatug and our next generation blood-brain barrier EBD candidates and highlighted the important work and upcoming milestones that lay ahead. That message has not changed. In the first quarter, we continued to advance Subirnatug through our phase two altitude AD trial, building on the clinical momentum established over the past year. The study remains a critical proving ground for our central scientific thesis that selectively targeting synaptotoxic A-beta oligomers rather than amyloid plaques may constitute a more effective and or safer path forward in Alzheimer's. Execution has stayed on track. Participants have been transitioning smoothly into the 12-month open-label extension study, and the conversion rate remains high. We see this discipline progress is bringing us closer to a potentially differentiated treatment option for people living with Alzheimer's. We expect our top line results for Altitude AD late this year. As we've described, Altitude is designed as a well-powered study to detect statistically significant difference after 18 months on our primary clinical efficacy endpoint, the amount of slowing as measured by the IDRIS. We expect to also report on key secondary endpoints in the top line results, such as the clinical dementia rating score sum of boxes, certain safety measures, such as adverse event rates, including ARIA rates, and key fluid and imaging biomarkers. The study is designed to evaluate safety and efficacy of two dose levels, 35 and 50 milligrams per kilogram, compared to placebo. Both of the active doses are within the range of exposures shown to have exhibited pharmacodynamic target engagement in our intercept AD phase 1 trial. Our enhanced brain delivery EBD program is also advancing nicely. We are conducting additional preclinical work to fully establish canop profiles and are very pleased with the output. We intend to submit a notice to exercise our option to license two compounds developed as part of our collaboration with JCR Pharma in the second quarter of 2026. So this development is imminent. We expect to discuss those candidate profiles in greater detail at a future medical meeting and continue to anticipate an IND filing in mid-27. We view EVD as a way to enhance our antibodies, enabling the potential to develop treatments with increased penetration and distribution in the brain while maintaining a favorable safety profile and allowing for patient-friendly subcutaneous dosing. We recognize there is competition in this space, however, none with an A-beta oligomer targeted therapeutic cargo. This is where we see the potential to push the therapeutic index even further, attaining efficacy by engaging the soluble toxic species of A-beta throughout the brain. Also, JCR, our collaborator on our ABD program, has clinically validated transferrin targeting blood brain barrier receptor mediated transcytosis technology. JCR has an approved therapy in Japan which incorporates their technology and has exhibited little to no anemia. This anemia safety profile offers us further potential for differentiation with our carrier plus cargo EBD product strategy. Taken altogether, our EBD program adds optionality to our pipeline as an additional oligomer targeted therapeutic strategy. While not currently contemplated in our immediate clinical development plans, an anti-abate oligomer EBD therapeutic could also potentially be studied in preclinical Alzheimer's, a population earlier in the disease course that could benefit greatly from a next-generation oligomer-directed approach. The progress we've made with Subirnatug and our next-generation EBD candidates reflect the strength of our science and ability to execute and sets a solid foundation for an exciting remainder of the year. I look forward to updating you on the imminent candidate selections in our EBD program and on our Altitude AD Phase 2 results in late 26. And with that, I'll turn the call over to Matt.

Disclaimer

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