Q3 2025 Acumen Pharmaceuticals Inc Earnings Call

Good day and welcome to the Acumen farmer. Third quarter 2025 conference call and webcast. At this time, all participants are listening 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 answered and you'd like to remove yourself from the queue press star 1 1 again.

How long to turn the call over to Alex? Braun head of investor relations. Please go ahead.

Thanks, Michelle. Uh, good morning and welcome to the occupant conference. Call to discuss our business update and financial results for the quarter ended, uh, September 30th 2025.

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

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 2 of our corporate presentation. Our press release issued this morning and our most recent annual and quarterly reports filed with the FCC for important risk factors. That could cause our actual results to differ materially from those expressed or implied in the forward-looking statements.

In the third quarter, we continue to our track record of operational. Execution on 2 front, the steady progression of our Phase 2 altitude, add trial and the generation of additional non-clinical data, supporting our enhanced brain delivery or EBD program.

Subunit, plug, selectivity for toxic ligands is central to why we believe it could unlock potentially greater clinical efficacy and improve safety relative to antibodies targeting Omalo plaque.

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 sabernet tug at 35 mg per kilogram, every 4 weeks for up to 52 weeks.

Based on our strong execution, we continue to expect Topline results for altitude. Add 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 Oliver 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 Q 2 calls. In August, we announced that strategic collaboration option and license agreement with jcr, Pharmaceuticals to develop an Alzheimer's disease product, combining our a beta illegal work selective antibody. Expertise with jcrs transferring receptor targeting, blood brain barrier, technology,

As part of this effort on the cargo or effector side of the construct. We are evaluating Serna tug and other Igor selective antibodies from our library including an antibody, we're calling AC, 234 that may have even greater selectivity for a later nurse over monomers compared with Suburban type.

The carrier portion. We're exploring both single chain and variable, heavy domain antibody constructs from jcr, extensive, uh, TFR targeting libraries, which we consider Cutting Edge, approaches in the BBB space.

The program is progressing nicely and we expect to present meiring 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 2 development candidates under our exclusive option agreement with jcr.

Finally, I would like to highlight the addition of Dr. George golden beske to our board as chairman with his edition board, has increased to 8 and George brings more than 30 years of experience in the biotechnology industry. And it's a highly recognized and experienced biofarma 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 2 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.

Matt, I think you might be on mute. Yes, apologies. Uh, thank you, Dan.

Quarter 2025 financial results are available in the press release we issued this morning and in our 10-Q, which we will file later today.

As of September 30th, 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 of the prior year, was primarily due to a reduction of cro costs associated with the altitude, add clinical trial for which we completed enrollment in March 2025 following dosing about of the first patient in May 2024.

G&A expenses were $4.5 million in the third quarter, decreasing primarily due to reductions in legal fees, audits 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, add and we look forward to sharing Topline results in late 2026.

Our EBD program also offers optionality and further unlocking the potential of targeting synaptic toxic A beta ligands for improved outcomes in treating Alzheimer's disease. We will have more to share on that in early 2026.

Through this 2 pronged approach. We remain dedicated to delivering potential Next Generation treatment options for the benefit of patients, caregivers and shareholders.

And with that, we can open the call for Q&A operator.

Thank you as a reminder to ask a question. Please press star 1, 1 1.

And our first question comes from Jason zamansky with Bank of America. Your line is open,

Good morning. Congrats on the progress and thanks for taking our questions. Uh, 2. If I may please, can you disclose what you're looking for in the early transfer and data. In terms of a go no-go decision, I mean what does it take to feel confident? The the delivery mechanism is is efficient enough and then maybe secondarily. Uh, can you talk a little bit about, uh, the evoke trials, the the novo studies of, of w Govi in in Alzheimer's and, you know, if it's positive, how does that impact the space and, and your approach? Thanks so much.

Hey, thanks Jason. I'm actually gonna invite Jim Authority, our chief development officer to comment. Actually on both of those questions. I think Jim is is a good uh source of response. Yeah, happy to you Dan. Uh and thanks. Jason for the question as as we think about the EBD program, you know, we do see an awful lot of opportunity and potential uh, by really being able to increase the penetration of super like antibody in the brain. And, you know, there there's not an absolute number that we think about, uh, as a, as a target for the fold increase that we're looking for or something like that. But, I can certainly tell you, as we look at the profile of suburban side. We remain very confident in Sovereign with those overall profile and, uh, we're excited about where we are in Phase 2. So, as you think about a Next Generation approach? We're really just looking at enhancing the, the overall profile for S. So given the relatively low penetration of any monoclonal antibody into the CNS. A a, a

Moderate increase in exposure. Level could have beneficial effects in multiple different dimensions and we, we see opportunities when it comes to efficacy, uh, when it comes potentially to safety, uh, given the findings so far with, monoclonal antibodies, uh, uh, being used with EBD for Alzheimer's disease and even for things like uh, drug delivery when it comes to total volume delivered, and things like that. So, as we think about it, we're looking for a meaningful increase in the overall exposure. Uh,

And, and we can achieve that at relatively low levels because of the the potent effects of some burnout already.

Ity going for other complimentary mechanisms of action in treatment of add there. It's clear that there are a lot of patients who who who need help. And I think some of these other alternative approaches could be interesting to pair with AMOLED approaches, like, subverting them.

Thanks for the caller.

Thank you.

Thank you. Our next question comes from, Tom Shrader with bcig. Your line is open.

Good morning. Uh thanks for the taking the questions. Oh you made an interesting comment about possibly replacing surna tug with something that's more a ligament focused. Uh maybe you can outline your thoughts there because what the shuttles allow you to do is remove plaque safely. So the other approach is to use something that's more plaque focused because, you know, if you can do it safely, you might as well. So, I'm just curious, you know, the thoughts of insiders and then for early data for the, the, the shuttle,

Is the sense that it's all about anemia, 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 sir. Thanks Tom. I'll make a quick comment and then Jimmy like to add on, I think 1 of 1 of the important facets of the jcr collaboration was for us to explore diversity of constructs. And so that's really where um, we're not seeking to replace sabera, but we're looking to explore, you know, what other possibilities exist as we sort of work through this, uh, Discovery phase effort. So that's I think that's the, the principle of play in terms of things, uh, Beyond sauna type. So we think that's an interesting, you know, gives us some redundancy and diversity in that, uh, that early stage program. Um, and we're, you know, we're here to, you know, so far, um, we're seeing some interesting results and are excited to to, you know, complete the data package by uh, by early next year.

Um Jim, do you want to take the the the further question from Tom on on anemia and how we're thinking about um at the tops and selectivity. Yeah, happy to do Dan Tom, we as as well as others are, are really excited about the technology. And I think it's uh, there's a lot of opportunity. It really comes down to framing it the way Dan's framed it earlier in the call around, uh, the combination of cargo and carrier. So, uh, obviously the, uh, 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, by the components. So when you think about things like uh, the risk factors, I mean the risk factor for Arya that has been associated with transferring based, approaches comes with the technology. Uh, so no.

Reason for us to think that the uh, the profile to date with Subaru shows any sign of, you know, such considerations. Um, but it certainly is the case with the technology. So our ways of thinking about it are at the moment that we we are very much focused on understanding what the combination of pairing amount of clonal a beta, uh, for cyber ligaments with transparent. So as we do testing for individual, um, constructs were looking at the the risks or, you know, potential for seeing anemia related effects, uh, with the constructs, but we do think that it's likely if we see anything like that, it would, the contribution will be coming from the transparent based construct. I ultimately, at the end of the day, this is why you do testing and select a particular, um, candidate molecule to, to sort of maximize benefits and minimize risks. But from first principles, that's our thinking, and that's where the expectation would be, is that it would be

A risk carried by the transparent technology part of the reason that we selected, uh, jcr as a partner is, they've got a track record in the clinic of being able to minimize that risk with their constructs.

Perfect, thanks for the thoughts.

Thank you. Our next question comes from Jeff Meacham with City. Your line is open.

Hi guys, it's Ross on for Jeff. Uh, thank you for taking our question. Um, we had a question on the non-clinical data package, uh, specifically. We are curious what data we could expect to see and specifically, in regards to, what biomarkers you would be looking at. Thank you.

Thanks for asking. You want to take that?

Construct. So, we want to make sure that the Suburban tug like profile that we have, uh, is not negatively impacted by adding the, uh, um, the, the cargo and the carrier construct. And then, of course, we're also very much interested in the impact of the carrier construct on PK profile. Both, uh, looking at the, the increase in brain penetration, but also looking at the pharmac the, that is 1 place where there is diversity from Canada to Canada. So we look at PK profile. We'll be looking at, uh, binding to algor and other a beta targets. And we'll be looking at some urine animal models as well to see if we can see, um, profiles consistent with what we've demonstrated to date with Suburban dog. So that's the and of course, Very importantly, we'll also be including a uh, primate PK study because of course, the muring stuff is very important, but no substitute for uh looking at what's happening in the primate brain especially with uh the transparent

Receptor constructs, which the the uh the primate version of transparent is a little different than the, than the mirroring.

Uh, so that's how we're thinking about the delivery of the package for, um, selecting a candidate to move forward with, uh, the program moving forward. After that, we benefit very much from the fact that Sabrina TUG 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 Sabrina TUG. And so we see a real opportunity as we go into.

Early. Phase clinical developments to build off of that. And so, what you'll see is a lot of the same biomarkers that we've looked at, uh, in the suburbs, they're thinking about the, uh, plasma based biomarkers looking at a beta 4042 levels looking at, uh, ptow levels including ptow. 217, and then also, including the downstream synaptic markers, like, uh, neurogan and and Vamp 2. And and really we we it gives us an a lot to build on from our uh lead program to to be able to understand how the the carrier enhanced subura tug program is doing.

Thank you.

Thank you. Our next question comes from Paul Matis with Steeple. 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, you know, will these candidates will both candidates be advanced in unison? Or is there a chance of advancing 1 and then waiting for the altitude results before advancing the other and in terms of selecting the other non-supported tug candidates, you know, other than specificity were there, other things you considered that might be optimized. Thanks,

Yeah, thanks for the question. I think it's it's too early for us to say, whether we'll be advancing 1 or 2 and which of the 2 might move forward. So I think we're, you know, this is going to be data dependent in early 26 and um, I do think we're looking at a combination of factors around the the subura 234. I mean, it it's we're still generating more data around selectivity and other properties. Um, but our, our intrigued to think that, um, you know, there's there's other profiles, even still be on uh, primary suburbanites that that could be, uh, candidates for further development.

Thank you.

Thank you. Our next question comes from Pete. Steph rapalus with cancer. 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. So, my first question, um, I know we're about a year or so away from altitude 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. Um, and then I just have a quick follow-up. Thank you.

Thanks, Samantha. Uh, Jim or Eric, do you guys want to provide a primary response on that?

The uh, the, the effects on those clinical scales. So uh, we're of course, looking for uh a clear and demonstrable uh effects. Uh when you come down to change from uh, progression rate, but we're also going to be looking at what the overall impact of that is. And and looking at uh, the the deaf the effects of subverting talk about multiple scales. So we certainly have addresses our primary but there are a number of scales that are going to go into that. And and really in addition to just looking for

A clear signal, we're going to be looking for, what's the type of response in in those various scales? And I think the same kind of thing, uh, around the biomarker work, we're very excited with the biomarker signals. We're seeing after 3 months of dosing from uh, The Intercept study and so, this gives us much more data over a much longer period of time within 18-month primary endpoint. So that's kind of how we're looking at the readout itself. But uh, let me, let me turn over to Eric and see if he has any other colors that he wants to add.

Yeah, well, it's a great question. And thanks. Um, because at the end of the study, like a fairly large Phase 2 study, uh, like the altitude, um, it's really a matter of safety and efficacy. And as Jim mentioned, our primary outcome is this scale called the address, which is a combination of um, cognition and function. Um, so that's going to be our primary outcome in terms of efficacy. Although, as Jim mentioned, we...

We've got a lot of secondary measures in there too. And then you have to combine that with safety and it's the 2 of those in combination that give you the therapeutic index. And in a study, as large as altitude with 542 people, um, you, you really can get a sense of what that therapeutic index is now beyond that. Um, as you know, in our Phase 1 Study, we actually had some, uh, I would say fairly impressive biomarker responses which really tells us. Uh, not only do we have Target engagement in terms of uh finding the igmr, but we're also having effects on the downstream pathology and Alzheimer's disease. And of course, we'll look for those kind of biomarkers, uh, in

Uh altitude uh but based on the fact that we saw those even in our our small Phase 1 Study, um I think that could give us uh a real potential for being differentiated from a uh, other treatments.

Thanks sir.

Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Alex Braun for closing remarks.

Thanks, Michelle. And thanks to uh, everyone who tuned in today, uh, to listen to our Q3 update. Um, we are always available at the company for any uh, further questions. So please don't hesitate to get in touch, um, with that. Have a great day.

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