Earnings Call Transcript - ABOS Q1 FY2026

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.

Alex Braun, Head of Investor Relations

Thanks, Deedee. Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended March 31, 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 Seemers, 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.

Daniel O'Connell, CEO

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 Sobernatug and our next-generation blood-brain barrier EVD 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 Sobernatug through our Phase II 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 with 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 address 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 I trial. Our enhanced brain delivery EBD program is also advancing nicely. We are conducting additional preclinical work to fully establish candidate 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 EBD 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 all together, 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, and anti-A beta 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 Severnatug 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 in on our Altitude AD Phase II results in late 26. And with that, I'll turn the call over to Matt.

Matt Zuga, CFO

Thank you, Dan. As a reminder, our first 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 March 31st with $128.4 million in cash and marketable securities on the balance sheet, which is expected to support our current clinical and operational activities into early 2027. This increase over the prior quarter is due to the private placement we completed in support of our EBD program that grossed $35.75 million, which we announced in March of this year. R&D expenses were $16.5 million in the first quarter. The decrease over the prior year was primarily due to a reduction in manufacturing and material costs, as well as a reduction in CRO costs associated with our Altitude AD clinical trial, which completed enrollment in March 2025. G&A expenses were $4.7 million in the first quarter, the decrease primarily due to reductions in legal fees, as well as reductions in accounting, consulting, and insurance expenses. This led to a loss from operations of $21.1 million and a net loss of $20.7 million in the first 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. And with that, we can open the call for Q&A. Operator?

Operator

Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. And our first question comes from Pete Stavopoulos of Cantor Fitzgerald. Your line is open.

Pete Stavropoulos, Analyst — Cantor Fitzgerald

Good morning, Dan and team. Congratulations on the continued execution of altitude. A question sort of about altitude and, you know, altitude is looking at Alzheimer's disease, you know, similar to the approved amyloid beta antibodies. However, there are ongoing studies for preclinical Alzheimer's with a Phase III readout starting in 2027. You know, assuming that altitude is positive and you move forward with Sobernatov, can you just give us your current thoughts on which populations or patient types you would target in Phase III studies? You know, what would trigger you to expand to preclinical Alzheimer's?

Daniel O'Connell, CEO

Thanks, Pete. And I can address that real quickly. In terms of our focus, we remain focused on the early AD population, such as we've enrolled in altitude, AD, and see that as the path forward for Sobernatin in a future registration study. I think our interest in the preclinical population remains quite high, and as I mentioned, you know, potentially part of the future opportunities ahead for, principally for an EBD candidate. So that's not an immediate part of our plans, but certainly I think the science and mechanism and neutralizing toxic oligomers in the early course of the pathogenesis of disease is something that is promising on the horizon.

Pete Stavropoulos, Analyst — Cantor Fitzgerald

All right, thank you. And another question, please, on the EBD program, you know, you do have different versions of 193 and 234. They have different PK profiles, at least which was shown to date. What are sort of the key properties in preclinical data that will drive you or drive the decision on candidate selection and you know with an ind targeted i believe mid-2027 you know if you just walk us through how you're thinking about development plans and trial designs sure that's

Daniel O'Connell, CEO

that's a lot so i think as you know we've explored a lot of diversity in the evd program both from a carrier and cargo perspective and we and we like sort of the uh having the ability to evaluate a series of candidates we were down to a short list and as i mentioned we anticipate exercising our option for two candidates in the second quarter and remain confident that we would be filing an IND mid-2027. I don't know that we can go into the details of specific PK properties, but as we have characterized, I mean, the advantages of EVD really have to do with broad brain distribution, potentially a wider safety margin, and the simultaneous dosing convenience. So, those are elements of what we are using as part of the filter for prioritizing candidates in that program. Jim Doherty, who's on the call, I don't know, Jim, if you want to add some additional color to comment on Pete's question. Yeah, no, I think that sounded great,

Jim Doherty, Analyst — Other

Dan. I guess, Pete, the only other thing I would add, you asked about clinical programming. I mean, it's early days, so we're still thinking about what the early phase clinical program is going going to look like, but I think we have a huge benefit in having conducted the INTERCEPT study with Sivarnatog, and it really gave us quite a lot of data, not only the safety and tolerability and PK data you typically get in a phase one study, but since we were looking at Alzheimer's patients in the MAD phase, we were able to collect data on PET imaging for A-beta, for biochemical biomarkers for a number of different things. And that's really helped us with the Sabernituck program. And so we're actively discussing how to incorporate that kind of thinking into the early clinical studies for the EBD program. So more to come, but we're modeling what we've done on the Sabernituck program as a way to go forward. All right. Thank you very much

Operator

taking my questions. Thank you. And our next question comes from Jeff Meacham of Citi. Your

Mary-Kate Davis, Analyst — Citi

line is open. Good morning. This is Mary-Kate Davis. I'm for Jeff. Thanks for taking our questions. Just was wondering, could you please walk us through the early physician interest and feedback of Soberna Tug, especially given the unmet need in early Alzheimer's and mechanism of the treatment? And then as a follow-up, could you just walk us through the ongoing regulatory interactions and anticipated discussions for the late stage development of the program. Thank you.

Daniel O'Connell, CEO

Thanks, Mary-Kate. And actually, Jim, why don't you take that, um, Jim and Eric, I think on the, on the feedback we've received, we've done a lot of work at meetings and visited with a number of KOLs and other, uh, clinicians that, um, have provided a broad set of feedback on the Soberna Tug program, uh, in particular.

Jim Doherty, Analyst — Other

Yeah, happy to do that, Mary-Kate. And, and, uh, as Dan says, we, we've spoken to quite a number of KOLs about the Soberna Tug program. And, you know, I think there's a lot of interest, obviously. I mean, we're testing a hypothesis that is slightly different than what's been tested so far with the approved therapeutics. And I think, you know, we can talk about both what those therapies have been able to do in treating patients and where there's opportunity. And we do think that the Sobernatug approach offers a differentiated opportunity from what's been done to date. And I think that's generally understood by KOL. So, I think, you know, everyone's very much looking forward to seeing the data as we release the results for the altitude trial in late 2026, but I think at this point, there's a level of anticipation to see that potential for a differentiated response.

Eric Siemers, Analyst — Other

Yeah, and I might just add, we have spent a lot of time thinking about the differentiation of Sobernatog, and I think to sum it, well, obviously, we don't have the data right now. we're in a blinded trial, but when we get the data, one of the things that we'll look at, number one, would be efficacy, because, again, we target oligomers, which is different than the two approved drugs. And then the second thing is we'll look to see if we can differentiate on safety, because our antibody is an IgG2. The two approved antibodies are IgG1s. IgG1s have more effector function, the potential for more ARIA, and so we're going to look at the safety data very carefully when those become available. Yeah, and to your question around regulatory

Jim Doherty, Analyst — Other

interactions, the altitude study, of course, is running in multiple countries across multiple jurisdictions, so we're obviously speaking to regulatory agencies in the U.S. and Canada and in Europe as part of all that. And then thinking strategically about the program or, of course, engaging with regulators about the overall progress of both of our programs, both the suburb and suburb program as well as our APD programs. And so that's something we'll continue to do. Obviously, it's quite important to stay in contact and to keep them apprised of progress. And so that's just a fundamental thing that we're always doing.

Operator

Thank you. And our next question comes from Paul Matice of Stiefel. Your line is

Emily (on for Paul Matice), Analyst — Stiefel

open. Hi, this is Emily on for Paul. I want to say congrats on the quarter and just two quick questions from us. You know, as it relates to the upcoming phase two readout, you know, what do you think, you know, would be a clear win that would, you know, prove out to burn a tug to be a unique alternative to genetimab and lakenimab? And, you know, do you see kind of different scenarios with different doses um and then as a follow-up to that you know assuming success in phase two would you be able to incorporate a subcutaneous arm in a phase three program um and maybe any color on the feet on the subcutaneous timelines would be helpful too thanks so much thanks emily

Daniel O'Connell, CEO

so um i think in terms of a clear wind and altitude ad would be an efficacy signal um yeah, at least at 30% of flowing, which is sort of the maximal or the upper end of the boundary, I think, for the current approved agent. So, you know, we are hopeful and anticipating that by targeting toxic species in a directed fashion, selected fashion, that it will unlock greater efficacy. I think the safety profile, I think, you know, there's now real-world evidence to sort of suggest what the overall rates of aria, and of course, those rates of aria differ by genotype. And so, those are some of the other elements of what we'll be looking to establish in terms of ARIA. So, I think it will be the totality of the altitude data and really this sort of the risk-benefit profile with a combination of efficacy and or safety is positioned as the primary means of differentiation relative to the current approved agents. And in terms of sub-Q, I think we've previously guided that we will be looking at the Phase II data, particularly in respect to the two active doses that are being investigated in altitude to inform precisely where and how we would advance the ongoing work in sub-Q as part of the Phase III program.

Jim Doherty, Analyst — Other

And I might add, Emily, I think you asked an interesting question as well around doses. As you know, there are two different doses included in the altitude study. And those doses were chosen to sort of bracket the range of oligomer clearance as measured by our target engagement assay in phase one. So we think we've got an interesting range of doses chosen, and I'll be very curious to see how that impacts the results, both from a point of view of efficacy and safety, as Dan says. So that's an interesting feature on the altitude study is that we've got both of those doses to investigate.

Eric Siemers, Analyst — Other

Yeah, and just one other point about the aria. I think one of the concepts that's across the field now that's being better appreciated is that it's really symptomatic aria that you're really concerned about. And even of the symptomatic arias, it's serious adverse events that you really worry about. So those aren't nearly as common, but obviously they have a bigger impact. And so that's one of the things that we'll be benchmarking pretty carefully when we do get our data.

Operator

Great. Thanks, guys, so much. Thank you. And our next question comes from Jason Zemansky of Bank of America. Your line is open.

Jason Zemansky, Analyst — Bank of America

Good morning. Congrats on the great progress, and thanks so much for taking our question. I wanted to ask a question maybe from a different perspective here, but over the last several weeks, we've seen both the Cochrane report questioning the value of the anti-amyloid class, and I guess a few days ago, there was an article that detailed that use of the current commercially available anti-amyloid antibodies has been slower than expected. So, you know, as we kind of take a step back and think about both the overall unmet need and sort of the overall sort of view of the class itself, what do you think is necessary from Altitude and any sort of phase three you do to really demonstrate that there's a level of differentiation here, as well as, you know, overall, you know, efficacy to the point that it sort of turns back some of the skepticism?

Daniel O'Connell, CEO

Thanks, Jason. So I think in terms of the Cochrane report, I think it's been, you know, a good bit of follow-up in terms of methodology there, and I think there's a real question about kind of the merits of the approach from a methodology standpoint. I do think that, and I'm familiar with the STAT article as well, and I think it speaks to sort of two things, the unmet need and the demand for better options, and the fact that there is the clinical infrastructure is now has been established and continues to adopt and progress the the make available these first couple agents and build out essentially the marketplace i think what the the market is looking for is a more clear value proposition in terms of their risk benefit profile and that's really where you know leading out altitude and validating the I think Acumen and Severnitog stand at a really attractive position from a timing perspective to sort of re-energize the space and position next generation treatment options. I think, you know, the field has progressed over a number of years to develop better insights into clinical trial design, you know, which patients to treat, you know, underlying aspects of the pathophysiology of the disease. And so, you know, we view subreddit as sort of that next position, you know, advancing the field forward on the basis of positive data.

Eric Siemers, Analyst — Other

Got it. Thanks, McCullough. Again, I'd like to say that I was recently at the American Academy of Neurology meeting in Chicago, and these are practicing neurologists for the most part. There was a great deal of interest and enthusiasm for information concerning the two approved drugs, so canamab and denanumab. So even though there have been these relatively negative analyses, and again, as Dan mentioned, the Cochrane report was pretty flawed in a lot of people's opinions in terms of how they did the analysis. I think if you actually talk to neurologists, they understand that the infrastructure has been rate limiting, but that infrastructure is going to continue to improve. And so there is a lot of interest from neurologists at the AAN meeting.

Operator

Thank you. And our next question comes from Tom Schrader of BTIG. Your line is open. Good morning.

Alex Braun, Head of Investor Relations

This is Jenny Kim on for Tom Schrader. Thank you for taking our question.

Operator

At Altitude 80 approaches to the late 2026 top line readout, could you give us some additional color on the blinded operational metrics or tracking, things like protocol deviation rates, site level dropout patterns, or any shifts in enrolled patient population profile relative to your original assumptions? More broadly, what distinguishes the quality of this data set relative to prior and the Avaloy trial? Thank you.

Daniel O'Connell, CEO

Thanks, Jenny. Jim, do you want to lead out on that, and Eric, provide some color?

Jim Doherty, Analyst — Other

Yeah, Jenny, I'll give you a first pass and then ask Eric to weigh in. I think probably the best thing to say is that we, at this point, have been very pleased with the progress of the altitude study. Any of these studies is a 542-subject study. There's a lot of data and a lot of information flowing in the study, but we've been relatively pleased with the conduct of the study. It's a great team that is working extremely hard across multiple geographies to deliver the data. And I think, you know, to date, we have been tracking to the assumptions that we built into our study design. So we are we have confidence in our study design as well. And I'll I'll turn over to Eric to give you any specific commentary.

Eric Siemers, Analyst — Other

Yeah. So thanks for the question. The study is progressing quite well. I think, as you know, we completed enrollment in a very short period of time in 10 months. One of the things that we did in our study, which is being done in other studies that is quite innovative, I think, was to use this plasma PTAL 217 test as part of a screening procedure. So, in other words, when we did our phase one study, to get into the study, you had to have a positive PET scan, and it turned out that about 60% of the time the PET scans were negative. When we added this blood test, simple blood test, as a screening step before you got to PET scans, the rate of negative PET scans dropped from, again, around 60% to under 20%. So it made the screening process much better. We heard feedback from the sites that they really liked that approach. I think that's something that could be used in clinical practice, and actually at the American Academy of Neurology meeting, there was a lot of discussion about how you would use these plasma biomarkers as part of your screening process for patients. So we were really very pleased how that worked out in our trial, and we're looking forward to seeing that utilized in clinical practice.

Operator

Thank you for the color. Thank you. And our next question comes from Dev Prasad of Lucid Capital Markets. Your line is open.

Dev Prasad, Analyst — Lucid Capital Markets

Hi, congrats on the process and progress and thank you for taking our questions. Just following up on the previous question regarding Phase II doses, how much separation between 35 mg and 50 mg do you expect and what would you need to see to select a Phase III dose? Also, on EBD program, can you provide more detail on 14 to 40X higher brain exposure that you observed in the primates? What differentiated those exposures, such as dose, root, brain distribution, et cetera? Thank you.

Daniel O'Connell, CEO

Thanks, Deb. Jim, I'm going to direct those right to you.

Jim Doherty, Analyst — Other

Yeah, Deb, so happy to take those questions. So when we think about dosing for the altitude study first, the doses are 35 mg per kg and 50 mg per kg. And as I was mentioning earlier, those doses were sort of chosen with the idea in mind that that is what looks to be a key part of the dynamic range and exposure of soluble oligomers, which, of course, is our key primary target. And I think, you know, there's the opportunity to see effects, differential effects of the two doses in a couple of different ways. I mean, we'll have to wait and see what the data actually show, but one possibility is differences in efficacy. You might expect to see dose-related differences in efficacy, although I think part of what we're testing there is what the role of the SIBO oligomers is and how that's different from what you've seen to date with more plaque-targeting antibodies. So, in some ways, the lower dose may give more of an oligomer-specific signal, although we do expect some contribution from other species of A-beta even at that dose. And then certainly as you go to a higher dose, you would expect some additional effects on larger species, as we've seen in the Intercept study in phase one. And I think also one might expect that there could be some differences in tolerability, right? I mean, that would be, again, consistent with the phase one data. So, we're very excited to see the study at the end of the year, and we'll be looking at all these things for differential effects at multiple doses. And then I think your other question around the EBD programs. So, of course, what we're trying to achieve is both an improvement in brain penetration, but also the brain distribution of our oligomer-targeting antibodies by coupling with the carrier technology from JCR. And so what we've done is we've investigated multiple candidates is we've been able to vary both sides of that equation. So looking at the changes to the carrier choices from JCR, as well as modifications on the cargo side. And really, the quick way to summarize it is what you're seeing is a range of substantial improvements in brain exposure, and that's in both rodent studies using humanized transferent receptor, and then also in primate studies. And so we're looking at multiple brain regions in the primate study, and so we're seeing really substantial improvements, and you quoted the range between 15-fold and 40-fold improvements in exposure. And so we're seeing both that improved brain penetration as well as distribution. And we really think it's both properties that are part of what make this technology so exciting for the treatment of Alzheimer's and specifically for a soluble oligomer approach. So, that's what I can say to date. We are keeping a close eye on which are the best candidates to give us the broadest distribution in multiple brain regions.

Dev Prasad, Analyst — Lucid Capital Markets

Great. Thank you. Of course.

Operator

Thank you. This concludes our question and answer session and also today's conference call. Thank you for participating, and you may now disconnect.