Q1 2025 Acumen Pharmaceuticals Inc Earnings Call
The End of Part 2
Speaker Change: Good day and thank you for standing by. Welcome to the Acumen Pharmaceuticals, Q1 2025.
Conference call and webcast.
At this time, all participants are in a listen-only mode
please be advised that today's conference is being recorded.
Speaker Change: After the speaker's presentation, there will be a question and answer session. To ask a question please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1-1 again. I would not like to hand a conference over to your speaker today. Alex Braun, Head of Investor Relations
Alex Braun: Thanks, Josh. Good morning, and welcome to the Acumen conference called to discuss our business of state and financial results for the quarter ended March 31st, 2025.
Speaker Change: with me today, our Dan O'Connell, our CEO , and that Zuga, our CFO and Chief Business Officer.
Speaker Change: Dan and Matt have some prepared remarks and then we'll open a call for questions.
Speaker Change: 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.
Speaker Change: Before we begin, we encourage listeners to go to the investor section to Acumen website to find our press release issues this morning that we'll discuss today.
Speaker Change: Please note that during today's conference call, we may make forward-looking statements within the meaning of the federal security's laws, including statements concerning our financial outlook and expected business plans.
Speaker Change: Please see slide two of our corporate presentation, our press release issue 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 different materialism those expressed or implied in the forward-looking statement.
Speaker Change: 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.
So with that, I'll turn the call over to Dan.
Dan O'Connell: Great, thanks, Alex. Good morning, everyone, and thanks for joining us today.
Speaker Change: As we noted in our year end call in late March, Acumen continues to build and mention towards our goal of establishing suburnatog as a next generation treatment option for patients with mild cognitive impairment for mild dementia known as early Alzheimer's disease or early AD.
Speaker Change: In the first quarter, we completed a enrollment of our 542 participant phase 2 study, altitude AD, which is designed to evaluate the clinical advocacy and safety of suburnal tug-in patients with early AD.
Speaker Change: We completed enrollment of altitude in roughly 10 months, much faster than expected.
Speaker Change: We attribute the rapid pace of enrollment to the interest in suburnatog therapeutic potential as supported by an extensive non-clinical data set and positive phase one results.
Speaker Change: Innovative participant screening methods used in the trial and strong execution by our team and clinical partners. We expect top-line results for altitude AD in late 2026, inclusive of the key efficacy and safety measures.
Speaker Change: In April , we presented at two major Alzheimer's medical conferences, ADPD and AAN.
Speaker Change: Consistent with the rapidly growing focus on the utility of fluid biomarkers in AD, our presentations highlighted an innovative use of a plasma phosphotide to 17 screening procedure in altitude AD.
Speaker Change: Our study, combined with multiple recent clinical investigations, support the use of plasma, Pete Tao 217, and a sensitive indicator of the presence of amyloid pathology.
Speaker Change: Our objective for the PETAL-217 screening was to reduce the number of negative PET scans thereby streamlining the screening process.
Speaker Change: In our intercept phase one study, only 40% of individuals screened for participation in the study tested positive on AMOLED PET.
Speaker Change: In comparison, by screening for a specific threshold of PETA217 in altitude prior to a PET scan, 81% of screened individuals that met or exceeded the threshold tested positive on Amoled PET, a significant improvement.
Speaker Change: The use of the PETA-217 screening assay improved enrollment efficiency, decreased patient burden and reduced screening costs in altitude.
Speaker Change: We believe this approach contributed to our very rapid enrollment rate and serves as a clear example of how we consistently implement innovative approaches to AD drug development based on insights and emerging data from the field. [inaudible]
Speaker Change: Building off the intercept manuscript and biomarker changes that published in Q1 to the journal for the Prevention of Alzheimer's Disease. At ADPD and AAN, we also presented posters detailing other innovations our team has made to deepen the conversation around suburnatugs therapeutic potential.
Speaker Change: These innovations include insights into the early effects of suburnatog on synaptic biomarkers in AD.
Speaker Change: Methods to develop a beta-ligamor selective assays and a non-clinical model to test more precisely the interactions between suburnatog and a beta-ligamor that better replicates the human brain environment.
Speaker Change: Methods posters like these are important as they align with our view that abatoligomers are the most toxic form of amyloid in the Alzheimer's brain, and thus advancements to such assays and tools can help inform oligmer preference of selective drugs like suburnatide.
Speaker Change: As communicated on our UN call during the first quarter, we also completed a phase one study investigating a subcutaneous administration of subcutaneous and intravenous administration of subcutaneous and intravenous administration of subcutaneous and healthy volunteers.
Speaker Change: Importantly, results from a study showed that Suburnatok was well tolerated with systemic exposure, supporting the continued development of this route of administration.
Speaker Change: Our next steps for the development of subbarate type for subcutaneous administration involve ongoing formulation of drug delivery assessments.
Matt Zuga: And with that I'll turn the call over for Matt for the financials.
Speaker Change: Yeah.
Speaker Change: Thank you Dan.
Speaker Change: As a reminder, our first quarter 2025 financial results are available in the press release, we issued this morning and in our 10-Q, we will file later today.
Speaker Change: As of March 31, we had $197 $9 million in cash and marketable securities on our balance sheet.
Speaker Change: Which is expected to support our current clinical and operational activities into early 2027.
Speaker Change: R&D expenses were $25 $3 million in the first quarter <unk>.
Speaker Change: The increase over the prior year was primarily due to the increased spending to support the altitude <unk> trial.
Speaker Change: <unk> completed enrollment in March 2025.
Speaker Change: G&A expenses were $5 $1 million in the quarter roughly flat to the same period in the prior year.
Speaker Change: It's led to a loss from operations of $34 million and a net loss of $28 $8 million in the quarter.
Speaker Change: We are off to a strong start without two day D and we look forward to sharing top line results, which are expected in late 2026.
Speaker Change: We remain dedicated to delivering a potential next generation treatment option for the benefit of patients caregivers and shareholders.
Speaker Change: And with that we can open the call for Q&A.
Speaker Change: Operator.
Speaker Change: Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for questions.
Speaker Change: Our first question comes from Paula <unk> with Stifel. You May proceed.
Speaker Change: Hi, This is Matthew for Paul Thanks for taking my question and congrats on the progress. So a quick question on the sub Q once the formulation and drug delivery assessments are complete how are you how or when are you thinking about incorporating that into your future development plans. Thank you.
Speaker Change: Thanks, Matthew and then we've got Jim and Eric on the call I'm going to direct that went to Jim necessary to provide comment.
Speaker Change: Thanks, and Hi, Matthew Yes. So your question is as we get to next stages and our understanding of the subdued development, how do we integrate it into the program.
Speaker Change: There's a there's a couple of options that we have in front of us and that team is is working very hard on establishing what's going to be the most efficient pathway and I think basically the major options would include.
Speaker Change: Incorporating an arm.
Speaker Change: Sub Q administration into an ongoing.
Speaker Change: <unk> III study for IV suburban type that's plans based on outcomes from the altitude <unk> IV study or alternatively doing a standalone study.
Speaker Change: Looking at the FX sub to use a burn in side to be able to provide to the program. So those are the two major pathways and at this time. The team is still evaluating what's going to be the most efficient path forward. Ultimately that's our goal is to be able to most rapidly and effectively evaluate both opportunities for patients.
Speaker Change: Thank you.
Okay.
Speaker Change: Thank you.
Okay.
Speaker Change: Our next question comes from Pete Stavropoulos with Cantor Fitzgerald you May proceed.
Speaker Change: Hey, this is Jeremy Darius on therapy, we have a couple of questions. The first question being can you just remind us the powering assumptions for altitude and if there is an interim futility luck built into the study.
Speaker Change: Sure Eric do you want to quickly hit on that.
Speaker Change: Sure so.
Speaker Change: We do not have an interim analysis.
Speaker Change: The study initially there was some discussion about that possibility, but we made the decision not to do an interim analysis. There is really no need to do that.
Speaker Change: In terms of the powering.
Speaker Change: We haven't disclosed any specific numbers, but I can just tell you that the powering is very appropriate for a phase III study is 542 people. So it's.
Speaker Change: Not a small phase II.
Speaker Change: I actually had a fairly good sized phase II study.
Speaker Change: As appropriate for.
Speaker Change: Phase two study.
Speaker Change: Yes.
Speaker Change: Great and just a quick follow up there's been a lot of progress in the Alzheimer's space, many of which show that changes in Biomarkers could appear.
Speaker Change: The dance of symptoms.
Speaker Change: As well as some of the underlying pathology various species, how do these updates inform your approach and assumptions about the disease in clinical studies and understanding that the data is in late 2020 sacks with do you expect to show at the top line.
Speaker Change: Well thanks, Greg.
Speaker Change: Great question.
Speaker Change: As the field just made a lot of advances recently, especially in terms of these.
Speaker Change: Blood based plasma Biomarkers, which.
Speaker Change: Five years ago, probably people wouldn't have thought that was possible, but we're starting to see that now.
Speaker Change: What we did in our development plan for spirit side.
Speaker Change: Even in our phase one study.
Speaker Change: We did that in patients and we had a number of different biomarkers in the study.
Speaker Change: And interestingly, even in the Mad cohorts multiple dose cohorts, where they still only got three administrations of the drug we saw changes in.
These biomarkers that people are looking at pretty commonly so whether it's an and not everything was statistically significant.
Speaker Change: As one study, but directionally. It was very consistent so we had normalization of the a beta 42 of over 40 ratio, which.
Speaker Change: Correlates with the amount of amyloid plaque.
Speaker Change: We had decreases in different <unk> species.
Speaker Change: We had directional changes biomarker called <unk>, which is the astrocyte Mercury. So we had all these different things even in our own phase one study with just three administrations of drug go the right direction essentially so the field is really moving rapidly there.
Speaker Change: At this point I think it's safe to say that there is not a.
Speaker Change: Drives Lee accepted surrogate.
Speaker Change: A marker for Alzheimer's disease, So you still need clinical outcomes.
Speaker Change: Okay.
Speaker Change: To have approval it is our general expectation, but.
Speaker Change: By the way our phase III study the primary outcome.
Speaker Change: As the clinical measure of the scale of the Iris, but these biomarkers really give you.
Speaker Change: Really a good indication of central pharmacology.
Speaker Change: And I think we've talked about this before but we were just very pleased to see that even in a phase one study that we had evidence of central pharmacology.
Speaker Change: Of <unk> in patients with Alzheimer's disease. So it's really nice for somebody like myself, who has been in the field for quite a while to see these really rapid advances.
Speaker Change: Many of which are based on these these biomarkers that people are now better understanding and we now have the technology the tools to measure them better.
Speaker Change: And maybe just to amplify a little bit on what Eric saying and as you can hear we.
Speaker Change: A lot about biomarkers and including Biomarkers in our trials.
Speaker Change: Do.
Speaker Change: Most of the field at this point, so as Eric was saying there's been a tremendous amount of advancements in the last few years building off long history of trying to address these issues and I think you can see that progress is being made in.
Speaker Change: Understanding how to stage Alzheimer's patients as they move through this progressive disorder.
And also.
Speaker Change: Different types of Biomarkers may inform mechanism of action kind of question. So.
Speaker Change: Put some emphasis on static biomarkers.
Speaker Change: To be measures of underlying synaptic health and activity. So we do think that by the time, we're looking at readout from altitude AE.
Speaker Change: There's going to be a lot of value in biomarkers as context to add to the primary endpoint, which is Eric rightly points out of the cognitive endpoints, but there is a richness of the data that these biomarkers are bringing and so for US we think it's going to be an important part of the story and in addition to the markers that we're currently measuring we're also careful to do plasma sapling.
Speaker Change: To allow us to do additional work as as the field continues to learn.
Speaker Change: Great. Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question.
Speaker Change: It comes from Tom Shrader with <unk> you May proceed.
Speaker Change: Good morning, Thanks for taking my questions fairly related to the last questioner.
Speaker Change: It seems like the commercial antibodies are getting some traction in two companies are working very hard are you finding that poses any risk to your trial is your dropout rate about where you thought it would be given you had a placebo.
Speaker Change: Given you have a placebo arm and then I have a.
Speaker Change: Mechanistic.
Speaker Change: Yes, Great question I'll go ahead Sir.
Speaker Change: Well, okay, yes, so no. It's a good it's a great question and it's something that we've thought about quite a bit is because they are now our two FDA approved drugs at least in the United States.
Speaker Change: Could that be a risk to our study.
Speaker Change: And so far thats not been the case and as you know the the launch of both of those drugs with <unk> being a little sooner than having a little more history to it now has been relatively slow a lot of that we think is due to just infrastructure.
Speaker Change: Not being present and it will continue to be built but the bottom line is for our altitude study.
Dan O'Connell: Again, as Dan mentioned previously.
Dan O'Connell: Enrollment rate was much higher than we had actually projected so we enrolled.
Dan O'Connell: 142 people and 10 months, which is.
Dan O'Connell: Pretty substantial.
Dan O'Connell: But then in terms of discontinuation rates.
Dan O'Connell: This is an ongoing blinded trial.
Dan O'Connell: Finished.
Enrollment relatively short time ago. So.
Dan O'Connell: So far the discontinuation rate looks looks quite good. So we're not seeing problems with these marketed drugs one of the things to keep in mind is that we do have an open label extension at the end of the study so people who get randomized into altitude.
Dan O'Connell: So it's a three arm study one arm is placebo so.
Dan O'Connell: Answers or two out of three that youre not on placebo and then when you get to the open label extension.
Dan O'Connell: Percent of people, who will be on drug. So we think that's one of the study design aspects. That's really made this an attractive study for people and so far the studies.
Dan O'Connell: Progressing very nicely.
Dan O'Connell: Okay, and then for plus hotel <unk> and you guys are all over this this marker.
Dan O'Connell: Is this the best guess for the.
Dan O'Connell: For a useful treatment biomarker or is that not likely to be the case and do you have a sense of.
Dan O'Connell: Where we sit today, what's what's likely to be the best treatment biomarker do you think youre synaptic.
Dan O'Connell: Markers that are kind of novel or have a better chance, but where do we stand on a treatment biomarker, we understand staging biomarkers are quite advanced.
Dan O'Connell: Yes, Tom This is Jim happy to take that one as I was saying, we do definitely think that these.
Dan O'Connell: Plasma based biomarkers are going to be.
Dan O'Connell: Continuing to evolve and I think.
Dan O'Connell: As you just said staging is one clear used and I think that's coming along I think.
Dan O'Connell: Markers of activity or efficacy I think everyone is asking that question I think at this point, we don't yet know certainly detailed 217 is going to be critical in whatever it plays out.
Dan O'Connell: I think my guess and our guess is that we're likely to see a series of markers that are used to both understand where patients are in there and theyre all timers journey, but also.
Dan O'Connell: To be used to assess.
Dan O'Connell: Ongoing.
Dan O'Connell: Cognitive level I don't think were likely to see a single marker.
Dan O'Connell: A clear progressive.
Dan O'Connell: Marker of cognitive activity youre likely to see multiple markers, giving you.
Dan O'Connell: As patients continue.
Dan O'Connell: Beyond that we'll just have to wait and see but that would be my guess is that we'll see a number of different markers correlating with the progression of disease and that's part of what's happening right. Now is there are a lot of studies ongoing trying to work out which markers at which time, our correlating with function.
Dan O'Connell: So stay tuned.
Speaker Change: Yeah. The interesting thing about that question is that these biomarkers.
Dan O'Connell: Used either for diagnostic purposes or to assess drove it.
Dan O'Connell: One at a time the same biomarker can be used to do both.
Dan O'Connell: So it gets a little confusing in terms of what's the purpose of your biomarker, but but you can use either way either as a diagnostic or.
Dan O'Connell: As evidence of drug effect.
Dan O'Connell: Okay, great. Thank you.
Dan O'Connell: Thank you.
Speaker Change: Our next question comes from Tim Lugo with UBS you May proceed.
Tim Lugo: Good morning, and thank you for taking my question.
Falloff question biomarker, maybe focusing on the synaptic biomarkers.
Tim Lugo: Stephen there are increasing.
Tim Lugo: I'll leave my target therapy may differentiate in promoting fanapt, particularly recoveries, which are not much of it does seem that pod pocket these therapies yet.
Speaker Change: However, we've seen some recent data from Roche and we have Sean Johnson enough also meaningfully reduced.
Tim Lugo: Biomarker like New York Ranting.
Speaker Change: So can I ask what are you.
Speaker Change: Alex over the Ross data also maybe if you could talk about the overall.
Speaker Change: Mike.
Speaker Change: About your updated thoughts on how competitive the competitive <unk> shelf Bernie Todd versus continue Matt. Thank you.
Speaker Change: Thanks, Tim and I think Eric that kind of falls along the preview you gave of the intercept results, which were short duration study, but meaningfully moving.
Speaker Change: Some of the Abi the tile, but also the synaptic markers I think even the.
The debt to one of the one of the presynaptic markers achieving.
Speaker Change: Achieving significance across each of the higher dose cohorts.
Speaker Change: So I think.
Speaker Change: For a short duration study such as intercept.
Speaker Change: We are encouraged to think that altitude.
Speaker Change: Certainly positioned to readout.
Speaker Change: Potentially a more impactful and broader private way and we'll just we'll have to see I think.
Speaker Change: Sure.
Speaker Change: We're now positioned to read out the study next year, so excited about that prospect.
Speaker Change: Yes, right I mean intercept may not have been the very first study to measure these synaptic biomarkers, but it was certainly one of the first and as you point out for dinner map now for example.
Speaker Change: It's something that the field is looking at broadly so.
Speaker Change: We are pleased that we were one of the first studies to show effects on synaptic Biomarkers and obviously, we'll look at those in our altitude study in addition.
Speaker Change: Thank you.
Really helpful.
Speaker Change: Thank you I would now like to turn the call back over to Alex Brown for any closing remarks.
Speaker Change: Great. Thanks, Josh and thanks, everyone for taking the time.
Speaker Change: And all for joining US today, we are available at the company any time for additional questions.
Speaker Change: And with that I hope you all have a great day.
Speaker Change: Thank you. This concludes the conference. Thank you for your participation you may now disconnect.
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