Acumen Pharmaceuticals, Inc. Common Stock 2026 Q2 Earnings Call

Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended June 30th, 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 will open the call for questions. Joining for the Q&A session, we also have Dr. James 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 will 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 2 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 any accompanying presentation as a result of new information or future results or developments. With that, I will turn the call over to Dan.

Great. Thanks, Alex. Good morning, everyone, and thanks for joining us today. During the second quarter, our focus remained on disciplined execution as we advanced sabirnetug towards the highly anticipated top-line readout from our Phase II ALTITUDE-AD trial, which we continue to expect late this year. We believe this will be an important efficacy readout in the Alzheimer's field. ALTITUDE-AD remains a critical test of our central scientific thesis that selectively targeting synaptotoxic amyloid beta oligomers may offer a differentiated approach to treating Alzheimer's disease. A substantial body of evidence support this hypothesis, and we are excited by the opportunity to evaluate that thesis in a well-powered randomized Phase II study with clinically meaningful endpoints.

Our phase II results have the potential to substantially expand on our phase I results, which include a demonstration of A-beta oligomer target engagement and biomarker changes that we are seeing as early as 3 months of treatment, as we previously reported. We continue to be encouraged with the engagement of patients, caregivers, investigators, and study sites participating in ALTITUDE-AD, as well as in its 12-month open-label extension study. Their commitment has been instrumental in bringing us to this important inflection point. I believe the strong relationships the Acumen team holds with study sites and investigators is particularly supported by Acumen's patient-centric approach. At AAIC last month in London, we presented patient experience data collected from participants and study partners prior to treatment in ALTITUDE-AD.

Results illustrate the diverse ways individuals with early Alzheimer's disease experience, respond to, and cope with cognitive and functional changes, underscoring the importance of capturing patient experience directly to better understand the meaningful benefit at this stage of disease. As we have previously described, ALTITUDE-AD was designed to detect a statistically significant difference on its primary clinical efficacy endpoint, the ADAS-Cog, after 18 months of treatment with sabirnetug compared with placebo. We expect the top-line data set to include results from the primary endpoint, key secondary measures such as the CDR-SB, safety assessments including adverse events and ARIA rates, as well as important fluid and imaging biomarkers. The study is evaluating 2 dose levels, 35 milligrams per kilogram and 50 milligrams per kilogram, compared with placebo. Both these dose levels are within the exposure range previously shown to achieve pharmacodynamic target engagement.

While we remain focused on execution and preparation for the readout, enthusiasm across the organization continues to build as we approach this landmark catalyst. We believe that sabirnetug has the potential to demonstrate a differentiated benefit to risk profile given its unique product attributes as an anti-A beta oligomer IgG2 monoclonal. We look forward to sharing the results later this year. In the second quarter, we announced the nomination of 2 enhanced brain delivery candidates for the treatment of Alzheimer's disease, representing the only program combining a validated blood-brain barrier-penetrating technology with an anti-A beta oligomer selective therapeutic antibody. Building on robust preclinical data from both in vitro and in vivo studies, we exercised our option with JCR Pharmaceuticals and will advance 2 candidates, ACU301 and ACU401. ACU301 is a bispecific antibody incorporating sabirnetug, and ACU401 incorporates a novel next-generation A beta oligomer selective antibody with differentiated properties.

This is known as ACU234. We view our EBD program as expanding the optionality in our pipeline and will continue to evaluate both candidates in the lead-up to support a filing of an IND. Confirming our mouse data in non-human primates is a pivotal step in this work. At last month's AAIC conference, we presented data showing that after intravenous dosing, all 3 EBD bispecific antibodies achieved greater brain exposure than unmodified ACU234 alone. ACU401 in particular, achieved up to a 40-fold greater frontal cortex exposure in non-human primates, and significant increase in exposures in deep brain regions. The degree of brain penetration observed in cynomolgus monkeys, combined with preserved soluble A-beta oligomer selectivity and a clean hematological profile, exceeded our expectations and gives us confidence in the differentiated potential of our EBD program's approach. We continue to anticipate an IND filing for our lead EBD candidate in mid-2027.

Coming up, I'd like to flag for investors an anticipated virtual investor relations day to be held on September 16th. Please mark your calendars to view live or as a recording, as we hope this will be helpful review for the Acumen investment thesis prior to ALTITUDE-AD's phase II data readout. The advancement of sabirnetug in our next-generation blood-brain barrier EBD candidates underscores the strength of both our scientific platform and our ability to execute, positioning us well for a significant eventful remainder of 2026. I look forward to updating you on our EBD program and on our phase II results for sabirnetug late this year. With that, I'll turn the call over to Matt.

Thank you, Dan. As a reminder, our second quarter 2026 financial results are available in the press release we issued this morning and in our 10-Q we will file later today. We ended the second quarter with $110.2 million in cash and marketable securities on our balance sheet, which is expected to support our current clinical and operational activities into early 2027. R&D expenses were $27.8 million in the second quarter. The decrease over the prior year was primarily due to reductions in manufacturing and materials costs as well as CRO costs as we get into the final leg of our clinical trial. G&A expenses were $4.7 million in the second quarter, roughly flat for the same period in the prior year. This led to a loss from operations of $32.6 million and a net loss of $32.7 million in the second quarter.

We are confident in our scientific innovation and strong track record of execution as we work toward our phase II ALTITUDE-AD readout later this year and advance our EBD program. We remain dedicated to building value with our portfolio of A-beta oligomer targeted antibodies for Alzheimer's patients, caregivers, and stakeholders. With that, you can open the call for Q&A. Operator? Thank you. As a reminder, if you'd like to ask a question, please press star one one.

Thanks for the question. We saw the announcement of the blinded interim assessment. This is really early-stage data, so there is not too much we can conclude from that reporting or that announcement. We will be interested to see how that study reads out sometime early next year. We reported phase I results in 2023, which, to our view, established a really robust clinical target engagement of A-beta oligomers. With just three doses in that phase I study, we are seeing effects on both fluid and imaging biomarkers that sort of exceeded our expectations and underpin our confidence in why in a large study, in an efficacy-based study such as ALTITUDE-AD, sabirnetug is positioned for success.