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Acumen Pharmaceuticals reported its Q3 2025 earnings, revealing a net loss of $26.5 million. Despite the loss, the company’s shares rose 4.23% to $2 in premarket trading, driven by positive developments in its Alzheimer’s treatment trials. The earnings call highlighted the company’s strategic focus on its lead candidate, Sabirnetug, and its collaboration with JCR Pharmaceuticals.
Key Takeaways
- Acumen’s stock increased by 4.23% in premarket trading.
- The company reported a net loss of $26.5 million for Q3 2025.
- Positive updates on the ALTITUDE-AD phase two trial boosted investor confidence.
- R&D expenses decreased year-over-year to $22 million.
Company Performance
Acumen Pharmaceuticals continues to focus on developing innovative treatments for Alzheimer’s disease. The company’s strategy centers around its lead candidate, Sabirnetug, which targets A-beta oligomers. The completion of enrollment for the ALTITUDE-AD trial and the initiation of the open-label extension phase are significant milestones. These developments position Acumen favorably in the competitive landscape of Alzheimer’s treatment.
Financial Highlights
- Cash and marketable securities: $136.1 million as of September 30, 2025
- R&D expenses: $22 million, a decrease from the prior year
- G&A expenses: $4.5 million
- Net loss: $26.5 million for Q3 2025
Outlook & Guidance
Looking forward, Acumen expects to support its current activities into early 2027, with a non-clinical data package anticipated in early 2026. The company plans to select development candidates under its agreement with JCR Pharmaceuticals and anticipates top-line results from the ALTITUDE-AD trial in late 2026.
Executive Commentary
CEO Daniel O’Connell emphasized the company’s commitment to targeting synaptotoxic A-beta oligomers, stating, "Our core hypothesis remains that synaptotoxic A-beta oligomers play a pivotal role in the development of Alzheimer’s disease." CFO Matt Zuga expressed confidence in the trial’s execution, while Chief Development Officer Dr. Jim Dougherty highlighted opportunities in efficacy, safety, and drug delivery.
Risks and Challenges
- Potential delays in clinical trial results could impact timelines.
- The competitive landscape in Alzheimer’s treatment remains intense.
- Financial sustainability beyond early 2027 depends on successful trial outcomes and potential partnerships.
Acumen Pharmaceuticals remains focused on its strategic initiatives and trial developments, with a positive outlook supported by recent progress in its Alzheimer’s treatment programs.
Full transcript - Acumen Pharmaceuticals Inc (ABOS) Q3 2025:
Michelle, Conference Call Operator: Good day, and welcome to the Acumen Pharmaceuticals Third 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, please press star 11. If your question has not been answered and you would like to remove yourself from the queue, press star 11 again. As a reminder, this call may be recorded. I will now turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.
Alex Braun, Head of Investor Relations, Acumen Pharmaceuticals: Thanks, Michelle. Good morning, and welcome to the Acumen Conference Call to discuss our business update and financial results for the quarter ended September 30, 2025. With me today are Daniel 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 Dougherty, 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 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. With that, I’ll turn the call over to Dan.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: 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 non-clinical 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-AD is investigating sabirnetug, our humanized monoclonal antibody, with high selectivity for A-beta oligomers. Sabirnetug’s 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-controlled 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 sabirnetug at 35 mg per kg every four weeks for up to 52 weeks. The OLE represents not only our commitment to the participants involved in ALTITUDE-AD, but will also provide us with valuable long-term safety and additional efficacy data to supplement the broader data package supporting sabirnetug. 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 recognize 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 sabirnetug and other oligomer selective antibodies from our library, including an antibody we’re calling ACU234 that may have even greater selectivity for oligomers over monomers as compared with sabirnetug. 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 mirroring 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 Golembeski 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 two trial and EBD program to drive value for shareholders and Alzheimer’s patients alike. I’ll turn the call over to Matt for the financials.
Alex Braun, Head of Investor Relations, Acumen Pharmaceuticals: Hey, Matt. I think you might be on mute.
Matt Zuga, CFO and Chief Business Officer, Acumen Pharmaceuticals: Yes, apologies. Thank you, Dan. As a reminder, our third quarter 2025 financial results are available in the press release we issued this morning, and in our 10Q, we will file later today. As of September 30, we had $136.1 million in cash and marketable securities on the balance sheet, which is expected to support our current clinical and operational activities into early 2027. R&D expenses were $22 million in the third quarter. The decrease over the prior year was primarily due to a reduction of CRO costs associated with the ALTITUDE-AD clinical trial, for which we completed enrollment in March 2025, following dosing of the first patient in May 2024. G&A expenses were $4.5 million in the third quarter, the decrease primarily due to reductions in legal fees, audit, and other accounting services expenses and recruiting expenses.
This led to a loss from operations and a net loss of $26.5 million in the quarter. 2026 will be a very exciting year for Acumen. We are confident in our strong execution of ALTITUDE-AD, and we look forward to sharing top-line results in late 2026. Our EBD program also offers optionality in further unlocking the potential of targeting synaptotoxic A-beta oligomers for improved outcomes in treating Alzheimer’s disease, and we will have more to share on that in early 2026. Through this two-pronged approach, we remain dedicated to delivering potential next-generation treatment options for the benefit of patients, caregivers, and shareholders. We can open the call for Q&A. Operator.
Michelle, Conference Call Operator: Thank you. As a reminder, to ask a question, please press star 11. Our first question comes from Jason Zamanski with Bank of America. Your line is open.
Good morning. Congrats on the progress, and thanks for taking our questions. Two, if I may, please. Can you disclose what you’re looking for in the early transferrin data in terms of a go, no-go decision? I mean, what does it take to feel confident the delivery mechanism is efficient enough? Then maybe secondarily, can you talk a little bit about the Evoke trials, the Novo studies of Wegovy in Alzheimer’s? If it’s positive, how does that impact the space and your approach? Thanks so much.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Hey, thanks, Jason. I’m actually going to invite Jim Doherty, our Chief Development Officer, to comment actually on both of those questions. I think Jim is a good source of response.
Dr. Jim Dougherty, Chief Development Officer, Acumen Pharmaceuticals: Yeah, happy to, Dan. Thanks, Jason, for the question. As we think about the EBD program, we do see an awful lot of opportunity and potential by really being able to increase the penetration of sabirnetug or a sabirnetug-like antibody in the brain. There’s not an absolute number that we think about as a target for the full increase that we’re looking for or something like that. I can certainly tell you, as we look at the profile of sabirnetug, we remain very confident in sabirnetug’s overall profile, and we’re excited about where we are in phase two. As you think about a next-generation approach, we’re really just looking at enhancing the overall profile for sabirnetug. Given the relatively low penetration of any monoclonal antibody into the CNS, a moderate increase in exposure level could have beneficial effects in multiple different dimensions.
We see opportunities when it comes to efficacy, when it comes potentially to safety, given the findings so far with monoclonal antibodies being used with EBD for Alzheimer’s disease, and even for things like drug delivery when it comes to total volume delivered and things like that. As we think about it, we’re looking for a meaningful increase in the overall exposure, and we can achieve that at relatively low levels because of the potent effects of sabirnetug already. On the Evoke side of things, we are watching, as with everyone else, watching very closely to see what’s happening with the GLP-1 studies from Novo Nordisk. We think the science is really pretty interesting, and it’s certainly an evolving space, and clear that improving metabolic profile overall is having effects in a number of different patient populations.
I think there’s really good science behind the concept that improved metabolic profile could have a real effect for Alzheimer’s patients. We’re interested to see the outcomes. I think the key questions always come down to, in the specific trial, how well the agent is going to be delivered into the CNS, and I think that’s a fair question for Evoke and Evoke Plus. We’re just really glad to see activity going for other complementary mechanisms of action in treatment of AD. It’s clear that there are a lot of patients who need help, and I think some of these other alternative approaches could be interesting to pair with amyloid approaches like sabirnetug.
Thanks for the color.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Thank you.
Michelle, Conference Call Operator: Thank you. Our next question comes from Tom Schrader with BTIG. Your line is open.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Good morning. Thanks for taking the questions. You made an interesting comment about possibly replacing sabirnetug with something that’s more oligomer-focused. Maybe you can outline your thoughts there because what the shuttles allow you to do is remove plaque safely. The other approach is to use something that’s more plaque-focused because if you can do it safely, you might as well. I’m just curious the thoughts of insiders. For early data for the shuttle, is the sense that it’s all about anemia; is the sense that the anemia goes entirely with the shuttle domain so that your anemia should really be based on data from your partner, or is the anemia potentially also related to the actual payload, your actual antibody? Thanks for your thoughts.
Yes, thanks, Tom. I’ll make a quick comment, and then Jim would like to add on. I think one of the important facets of the JCR collaboration was for us to explore diversity of constructs. That is really where we’re not seeking to replace sabirnetug, but we’re looking to explore what other possibilities exist as we sort of work through this discovery phase effort. I think that’s the principle at play in terms of things beyond sabirnetug. We think that’s interesting—it gives us some redundancy and diversity in that early-stage program. So far, we’re seeing some interesting results and are excited to complete the data package by early next year. Jim, do you want to take the further question from Tom on anemia and how we’re thinking about epitopes and selectivity?
Dr. Jim Dougherty, Chief Development Officer, Acumen Pharmaceuticals: Yeah, happy to, Dan. Tom, we, as well as others, are really excited about the technology, and I think there’s a lot of opportunity. It really comes down to framing it the way Dan’s framed it earlier in the call around the combination of cargo and carrier. Obviously, the final product is going to have elements of both, but that also means that your overall profile is going to be dictated by the components. When you think about things like the risk factors, I mean, the risk factor for ARIA that has been associated with transferrin-based approaches comes with the technology. No reason for us to think that the profile to date with sabirnetug shows any sign of such considerations, but it certainly is the case with the technology.
Our ways of thinking about it are, at the moment, we are very much focused on understanding what the combination of pairing a monoclonal A-beta for soluble oligomers with transferrin is. As we do testing for individual constructs, we’re looking at the risks or potential for seeing anemia-related effects with the constructs. We do think that it’s likely if we see anything like that, the contribution will be coming from the transferrin-based construct. Ultimately, at the end of the day, this is why you do testing and select a particular candidate molecule to sort of maximize benefits and minimize risks. From first principles, that’s our thinking, and that’s where the expectation would be, that it would be a risk carried by the transferrin technology.
Part of the reason that we selected JCR as a partner is they’ve got a track record in the clinic of being able to minimize that risk with their constructs.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Perfect. Thanks for the thoughts.
Michelle, Conference Call Operator: Thank you. Our next question comes from Jeff Meacham with CITI. Your line is open.
Hi guys, it’s Ross on for Jeff. Thank you for taking our question. We have a question on the non-clinical data package. Specifically, we’re curious what data we could expect to see and specifically in regards to what biomarkers you would be looking at. Thank you.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Thanks, Ross. Jim, you want to take that?
Dr. Jim Dougherty, Chief Development Officer, Acumen Pharmaceuticals: Yeah, thanks for the question, Ross. Yeah, as we think about data package, I guess there’s a couple of ways that we think about that. One would be the data package that goes into a candidate selection decision, which we’re targeting for the early part of 2026. There, you can expect to see a number of preclinical studies looking at both the target profile for the new construct. We want to make sure that the sabirnetug-like profile that we have is not negatively impacted by adding the cargo and the carrier construct. Of course, we’re also very much interested in the impact of the carrier construct on PK profile, both looking at the increase in brain penetration, but also looking at the pharmacokinetics. That is one place where there is diversity from candidate to candidate.
We’ll be looking at PK profile, we’ll be looking at binding to oligomer and other A-beta targets, and we’ll be looking at some murine animal models as well to see if we can see profiles consistent with what we’ve demonstrated to date with sabirnetug. Of course, very importantly, we’ll also be including a primate PK study because, of course, the murine stuff is very important, but no substitute for looking at what’s happening in the primate brain, especially with the transferrin receptor constructs, which the primate version of transferrin is a little different than the murine. That’s how we’re thinking about delivery of the package for selecting a candidate to move forward with.
The program moving forward after that, we benefit very much from the fact that sabirnetug is currently in mid-stage clinical trials, and we’ve spent, as you know, a lot of effort in understanding biomarker profiles for the original sabirnetug. We see a real opportunity as we go into early-phase clinical developments to build off of that. What you’ll see is a lot of the same biomarkers that we’ve looked at in the sabirnetug program. Thinking about the plasma-based biomarkers, looking at A-beta 40/42 levels, looking at pTau levels, including pTau217, and then also including the downstream synaptic markers like neurogranin and VAMP2. It gives us a lot to build on from our lead program to be able to understand how the carrier-enhanced sabirnetug program is doing.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Thank you.
Michelle, Conference Call Operator: Thank you. Our next question comes from Paul Matisse with Stifel. Your line is open.
Hi, this is Matthew on for Paul. Thanks for taking our question and congrats on the progress. I guess on the shuttle program, I was wondering, will both candidates be advanced in unison, or is there a chance of advancing one and then waiting for the ALTITUDE-AD results before advancing the other? In terms of selecting the other non-sabirnetug candidate, other than specificity, were there other things you considered that might be optimized? Thanks.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Yeah, thanks for the question. I think it’s too early for us to say whether we’ll be advancing one or two and which of the two might move forward. I think this is going to be data-dependent in early 2026. I do think we’re looking at a combination of factors around the ACU234. I mean, we’re still generating more data around selectivity and other properties, but I’m intrigued to think that there’s other profiles even still beyond primary sabirnetug that could be candidates for further development. Thank you.
Michelle, Conference Call Operator: Thank you. Our next question comes from Pete Stavropulos with Cantor. Your line is open.
Hi, Dan and team. This is Samantha on the line for Pete. Congrats on the progress, and thanks so much for taking our question. My first question, I know we’re about a year or so away from ALTITUDE-AD data, but I’m wondering what your current thinking is in terms of the bar and what’s the minimum you’d like to see out of this study to move forward from both a clinical scale perspective and biomarker data. I just have a quick follow-up. Thank you.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Thanks, Samantha. Jim or Eric, you guys want to provide a primary response on that?
Dr. Jim Dougherty, Chief Development Officer, Acumen Pharmaceuticals: Yeah, so let me start, and I’ll invite Eric to jump in. Great to hear from you, Samantha. I think the answer to the question is this is we talk a lot about testing the oligomer hypothesis, and we think for a lot of reasons there’s the vast amount of evidence that speaks to oligomers having an important role in the pathophysiology of Alzheimer’s disease. I think our phase one data so far supports that. The key value in the ALTITUDE-AD study is it’s the first true demonstration looking at clinical scales. Obviously, the major impact for the study is to understand the effects on those clinical scales. We’re, of course, looking for a clear and demonstrable effect when you come down to change from progression rate.
We’re also going to be looking at what the overall impact of that is and looking at the effects of sabirnetug on multiple scales. We certainly have iADRS as our primary, but there are a number of scales that are going to go into that. Really, in addition to just looking for a clear signal, we’re going to be looking for what’s the type of response in those various scales. I think it’s the same kind of thing around the biomarker work. We’re very excited with the biomarker signals we’re seeing after three months of dosing from the INTERCEPT-AD study. This gives us much more data over a much longer period of time with an 18-month primary endpoint. That’s kind of how we’re looking at the readout itself.
Let me turn over to Eric and see if he has any other color that he wants to add.
Alex Braun, Head of Investor Relations, Acumen Pharmaceuticals: Yeah, it’s a great question, and thanks. Because at the end of a study, like a fairly large phase two study like ALTITUDE-AD, it’s really a matter of safety and efficacy. As Jim mentioned, our primary outcome is this scale called the iADRS, which is a combination of cognition and function. That’s going to be our primary outcome in terms of efficacy, although, as Jim mentioned, we’ve got a lot of secondary measures in there too. You have to combine that with safety. It’s the two of those in combination that give you the therapeutic index. In a study as large as ALTITUDE-AD with 542 people, you really can get a sense of what that therapeutic index is.
Now, beyond that, as you know, in our phase one study, we actually had some, I would say, fairly impressive biomarker responses, which really tells us not only do we have target engagement in terms of binding to oligomers, but we’re also having effects on the downstream pathology in Alzheimer’s disease. Of course, we’ll look for those kind of biomarkers in ALTITUDE-AD. Based on the fact that we saw those even in our small phase one study, I think that could give us a real potential for being differentiated from other treatments.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Thanks, Eric.
Michelle, Conference Call Operator: Thank you. I’m sure no further questions at this time. I’d like to turn the call back over to Alex Braun for closing remarks.
Daniel O’Connell, Chief Executive Officer, Acumen Pharmaceuticals: Thanks, Michelle. Thanks to everyone who tuned in today to listen to our Q3 update. We are always available at the company for any further questions, so please do not hesitate to get in touch. With that, have a great day.
Michelle, Conference Call Operator: Thank you for your participation. You may now disconnect.
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