Acumen Pharmaceuticals Q1 2024 Earnings Report

Acumen Pharmaceuticals EPS Results

• Actual EPS: -$0.25
• Consensus EPS: -$0.23
• Beat/Miss: Missed by -$0.02
• One Year Ago EPS: -$0.28

Acumen Pharmaceuticals Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Acumen Pharmaceuticals Announcement Details

• Quarter: Q1 2024
• Date: 5/20/2024
• Time: Before Market Opens
• Conference Call Date: Tuesday, May 14, 2024
• Conference Call Time: 8:00AM ET

Acumen Pharmaceuticals (NASDAQ:ABOS) is a clinical-stage biopharmaceutical company focused on the discovery and development of oral small molecule therapies for neurodegenerative diseases. Leveraging a proprietary drug discovery platform that integrates chemoproteomics, high-throughput screening and computational chemistry, the company seeks to identify and optimize compounds that selectively modulate pathological protein aggregation. Its approach is designed to address the underlying biology of conditions such as Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis and related proteinopathies.

The company’s pipeline comprises multiple lead candidates at various stages of preclinical and early clinical development. Its most advanced program targets abnormal tau aggregation in Alzheimer’s disease and has entered Phase 1 clinical testing. Additional preclinical candidates are designed to inhibit the misfolding or aggregation of proteins including TDP-43, alpha-synuclein, mutant huntingtin and transthyretin, with the goal of expanding its portfolio across a spectrum of neurodegenerative indications.

Founded in 2019 and headquartered in San Diego, California, Acumen Pharmaceuticals has assembled a management team with extensive experience in small molecule drug discovery and neuroscience R&D. The company completed its initial public offering in mid-2023, raising capital to advance its lead program through clinical proof-of-concept and to prepare select preclinical candidates for first-in-human studies. Acumen’s research and development efforts are complemented by collaborations with academic laboratories and contract research organizations across North America.

With a strategic focus on oral therapies that can be broadly administered in outpatient settings, Acumen aims to address significant unmet medical needs in the rapidly growing field of neurodegenerative disease treatment. The company’s leadership emphasizes rigorous translational science and biomarker-driven clinical development to accelerate the pathway from discovery to potential regulatory approval, ultimately seeking to improve quality of life for patients worldwide.

Acumen Pharmaceuticals Q1 2024 Earnings Call Transcript

Key Takeaways

• First patient dosed in ALTITUDE AD Phase 2 study, a randomized, placebo-controlled trial with ~540 participants to assess subornitag’s efficacy and safety in early Alzheimer’s.
• Encouraging Phase 1 INTERCEPT results showed rapid biomarker improvements after only three doses, driving strong investigator feedback and informing ALTITUDE’s two-dose arm design.
• Signed a collaboration with Lonza for clinical and potential commercial manufacturing of subornitag, leveraging their regulatory expertise and global production network.
• On track to initiate a subcutaneous formulation Phase 1 study in healthy volunteers by mid-2024 to match IV pharmacokinetics and offer patients greater dosing flexibility.
• Reported a robust cash position of ~$297 million, providing financial runway into the first half of 2027 to support ongoing trials and development activities.

Presentation

[Operator]

Good day, and thank you for standing by. Welcome to Acumen Pharmaceuticals' First Quarter 2024 conference call and webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one 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, Vice President and Head of Investor Relations. Please go ahead.

[Alex Braun, VP and Head of Investor Relations at Acumen Pharmaceuticals]

Thanks, Norma. Good morning, and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended March 31, 2024. With me today are Dan O'Connell, our CEO, and Matt Zuga, our CFO and Chief Business Officer. Dan and Matt have some 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 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.

[Alex Braun, VP and Head of Investor Relations at Acumen Pharmaceuticals]

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. So with that, I'll turn the call over to Dan.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

Thanks, Alex. Good morning, everyone, and thanks for joining us today. As we noted on our year-end call in March, 2024 is a year of execution for Acumen as we work to establish the therapeutic potential of sabirnetug as a best-in-class treatment option for the substantial early Alzheimer's patient population. I'm pleased to say that we were off to a great start with the first patient dosed in our ALTITUDE-AD Phase 2 study announced just last week. Altitude is a randomized, placebo-controlled double-blind study with three arms designed to evaluate the clinical efficacy and safety of sabirnetug with approximately 180 participants per arm for a total of 540 participants with MCI or mild dementia due to Alzheimer's disease. We were highly encouraged by the start of the Altitude study, which we attribute to a couple of key factors.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

First, we received positive feedback from site investigators on our phase 1 INTERCEPT-AD results. The thoroughness of the INTERCEPT-AD data package appears to be resonating, particularly the confluence of biomarker improvements we saw in patients after only 3 doses. Second, the design of the ALTITUDE-AD study has been viewed favorably by many investigators and patients. Because our phase 1 oligomer target engagement data was so informative, we are proceeding in phase 2 with two dose arms that may prove efficacious, so patients have a greater chance of receiving a therapeutically relevant dose level of sabirnetug. Additionally, the open-label extension is proving to be important to patients in the screening process as it provides for 12 months of sabirnetug active treatment following the 18-month placebo-controlled portion of the study.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

Overall, I'm extremely pleased with the strong foundation that our team and CRO partner have built with key trial sites, highlighting the benefits of preparation, communication for screening, and enrollment efficiency. In addition, we also recently announced a collaboration agreement with Lonza for manufacturing of sabirnetug for clinical development and commercialization should it be approved. This is important because it allows us to leverage Lonza's regulatory expertise, extensive experience in antibody manufacturing, and global manufacturing network. We are also on track to initiate a phase 1 study in healthy subjects for a subcutaneous formulation of sabirnetug in mid-2024. We believe a competitive product profile for sabirnetug includes a subcutaneous option to offer additional flexibility and convenience for patients and caregivers. We'll provide more information on the plan for that workstream once we have the PK results in hand.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

We remain committed to delivering on our strategic priority to efficiently and thoughtfully advance the clinical development of Sabirnetug for the benefit of patients, caregivers, and shareholders. I look forward to updating you as we work to achieve Altitude AD Phase 2 data that we believe will provide the true value inflection for the Sabirnetug program. And with that, I'll turn the call over to Matt for the financials.

[Matt Zuga, CFO and CBO at Acumen Pharmaceuticals]

Thanks, Dan. As a reminder, our first quarter 2024 financial results are available in the press release we issued this morning and in our 10-Q we will file later today. As of March 31, we had approximately $297 million in cash and marketable securities on our balance sheet and continue to expect that cash runway to last into the first half of 2027. R&D expenses were $12.4 million in the first quarter. The increase over the prior year was primarily due to the increased spending to support the Altitude AD trial. G&A expenses were $5.3 million in the quarter, with the increase over the prior year primarily the result of increased headcount. This led to a loss from operations of $17.8 million in the quarter. We are off to a strong start with Altitude AD.

[Matt Zuga, CFO and CBO at Acumen Pharmaceuticals]

We are well capitalized, execute on the study, and to develop a subcutaneous formulation of Sabirnetug. We are committed to delivering on the opportunity ahead of us and look forward to providing additional updates this year as we advance Sabirnetug for the benefit of patients, caregivers, and shareholders. With that, we can open the call for Q&A. Operator?

[Operator]

Thank you. As a reminder, to ask your question, you'll need to press star one one on your telephone. To withdraw your question, please press star one one again. Please wait for your name to be announced. Please stand by while we compile the Q&A roster. One moment for our first question, please. Our first question will come from the line of Tom Schrader with BTIG. Your line is now open.

[Tom Schrader, Managing Director and Healthcare Analyst at BTIG]

Good morning. Thanks for taking the questions. I have a couple of quick ones. First, for Matt, is R&D about stable now, or are we expecting it to go up significantly? I know you're probably early in enrollment, but you probably had some upfront costs. So where is R&D now compared to what you expect over maybe the next two years?

[Matt Zuga, CFO and CBO at Acumen Pharmaceuticals]

It's going to trend up for the next couple of quarters and then flatten out and then go down. But if you notice, R&D this quarter was more than any quarter that we ever had, and it's going to keep going to go up and sort of plateau for a couple of quarters and then come down.

[Tom Schrader, Managing Director and Healthcare Analyst at BTIG]

Okay, perfect. And then on the sub-Q formulation, do you have a sense of what you're looking for? Is the general idea here to do a quick study, show you can match AUC, and then maybe wait for the field to figure out if AUC is really the deliverable for a sub-Q antibody? Is that kind of the plan? Thank you.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

Thanks, Tom. This is Dan. I'll just quickly comment on that. Maybe Jim or Eric might care to. I think for us right now, I think the important thing is getting the healthy volunteer study up and evaluating the PK. And I think there is considerable optionality to observe sort of where the field heads, both from a clinical and regulatory perspective. So I think we're still sort of in the TBD as to the next step for sub-Q, but certainly want to get these Phase 1 results in hand as quickly as possible.

[Eric Siemers, CMO at Acumen Pharmaceuticals]

Yeah, and maybe just quickly, yeah, for the first study in healthy volunteers, I think the goal is really just to match AUC. The next study, which would occur in patients we haven't developed that plan, that designed that completely by any means. But since it'll be in patients, then we have a lot of other options in terms of biomarkers and target engagement and other things that we did in our INTERCEPT study. But this first study is just based on AUC.

[Tom Schrader, Managing Director and Healthcare Analyst at BTIG]

Okay, great. Thank you.

[Operator]

Thank you. One moment for our next question, please. Our next question will come from the line of Paul Matteis with Stifel. Your line is now open.

[Analyst at Stifel]

Hi there. This is James on for Paul. Thanks for taking our question. And maybe just to follow up on the sub-Q and just curious how you're kind of thinking has evolved. Do you think you can ultimately get to a plaque-busting dose with the sub-Q, or is the sub-Q more focused on oligomers? Just kind of curious what your thoughts are there. And then also maybe just quickly, just curious what you think about or what you're most interested in in the upcoming donanemab AdCom and what you think some of the implications may be for the broader A-beta space. Thanks.

[Eric Siemers, CMO at Acumen Pharmaceuticals]

Yeah, well, maybe I'll answer the first one and then pass it over to Dan for the second one or the others. But anyway, for the sub-Q, I don't think we look at that as being different than we saw in our INTERCEPT study in terms of plaque reduction versus oligomer target engagement. I mean, oligomer target engagement is something that's important for this antibody, but having some plaque reduction, as long as you can do it without a lot of ARIA, isn't a bad thing either. So the goal from that standpoint is really no different with the sub-Q effort versus the IV effort that we had in our Phase 1 study.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

Thanks, Eric. And James, in terms of the AdCom for donanemab, I think that session will principally focus on two main concerns that the FDA has raised in terms of the treatment duration and the tau stratification. So those will be important discussions to have sort of in the public forum, and I think they will likely have implications for label and market development. But ultimately, we do think that donanemab likely will be approved and will become a commercial marketer of a product in the Alzheimer's space, which we take as a positive as this is still sort of the early days of commercial infrastructure build and providing greater access to patients. So it certainly was a bit of a curveball for Lilly, presumably, but I think that the AdCom should go reasonably well and continue to underpin the growth of this treatment modality.

[Analyst at Stifel]

Makes sense. Thanks.

[Operator]

Thank you. Thank you. One moment for our next question. Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Your line is now open.

[Samantha Schaeffer, Biotech Equity Research Associate at Cantor Fitzgerald]

Hi, this is Samantha Schaeffer on the line for Pete. Now that you have presented the P1B data at multiple conferences and have extensively socialized the data, we're curious to hear if you have any updated thoughts on the potential mechanisms behind the lack of ARIA-E in ApoE homozygotes and observed only in females. Is this pattern just by chance, or is there a plausible mechanistic reasoning? Thanks for taking our question.

[Eric Siemers, CMO at Acumen Pharmaceuticals]

Yeah, you want me to go ahead and those are really good questions, and we've thought about them a lot. Of course, I'm not sure that we have an absolute answer to them. The fact that we didn't have any ARIA in the ApoE4 homozygotes, first of all, obviously, it's really encouraging for this particular antibody. But mechanistically, why that would be just to speculate, we could say not all plaques are exactly the same. Our antibody is targeting oligomers primarily with a little bit of plaque reduction or some plaque reduction in addition. So I think as we learn more about sort of plaques in general at a biochemical level, that we're going to start finding more and more that there are differences in plaques and differences in the way antibodies bind to different forms of plaque. But at this point, it's all speculation.

[Eric Siemers, CMO at Acumen Pharmaceuticals]

Obviously, in our Phase 2 study, we're going to be looking really carefully for ARIA in ApoE4 homozygotes. The question you raised about the fact that the ARIA cases were in women is a really good question, and interestingly, nobody has asked it before. But yeah, we've thought about that. And again, it's kind of like the lack of ARIA in the E4 homozygotes. It is a small study, and that could be by chance, the same as with the lack in the E4 homozygotes. But it does make you scratch your head a bit. And I think as we start to understand more about sex differences in whether it's the efficacy of the antibodies or, in this case, ARIA rates, there's just a lot that we don't know. And so that's another thing that we'll obviously keep a close eye on in our Phase 2 study.

[Eric Siemers, CMO at Acumen Pharmaceuticals]

But really good question.

[Samantha Schaeffer, Biotech Equity Research Associate at Cantor Fitzgerald]

Very helpful. Thank you so much.

[Operator]

Thank you. As a reminder, to ask a question, you'll need to press star one one on your telephone and wait for your name to be announced. Our next question comes from the line of Jason Zemansky with Bank of America. Your line is now open.

[Jason Zemansky, Managing Director at Bank of America]

Good morning. Thank you so much for taking our questions and congratulations on the progress. Curious, as far as your enrollment expectations for Altitude, especially given the availability of lecanemab and potentially donanemab in the future, can you talk a little bit about what you think the implications are and whether or not the availability of either or both of those antibodies are going to impact what you see? And then a follow-up, if I may.

[Daniel O'Connell, President and CEO at Acumen Pharmaceuticals]

Yeah, Jason. So thanks for the question. And I think based on the scripted word portion of the call, we were highly encouraged with the early phase of the Altitude study and encouraged at the rate of level of interest engagement from sites and how we're doing in the study generally. So I think for the moment, we feel really good about sort of the Phase 1 data informing and drawing patients' attention to the study. And I think as we we'll see where we get to as to the donanemab approval and so forth. But right now, we are feeling pretty good about the rate of enrollment in Altitude.

[Jason Zemansky, Managing Director at Bank of America]

Got it. And then as far as the subcutaneous formulation goes, is there a possibility or at least a protocol where you can use, if the healthy volunteer study goes well, use that within Altitude potentially? Is there some mechanism that would permit bringing that in, or would you have to wait for a separate study?

[Eric Siemers, CMO at Acumen Pharmaceuticals]

So I guess I'd take that one. Yeah, in our case, theoretically, of course, it would be possible to try to put it into Altitude. But Altitude is a Phase 2 study. It's completely designed. So I think that would be a challenge logistically to actually do. Again, what we will do after our healthy volunteer study for the sub-Q formulation is move to patients. And again, we can do a lot of the same things that we're doing in the Altitude study. In fact, we probably will. But I don't think you would try to insert that into the actual Phase 2 Altitude study.

[Jason Zemansky, Managing Director at Bank of America]

Got it. Thank you so much for the color.

[Operator]

Thank you. This concludes our Q&A portion. I'd like to hand the conference back over to Alex Braun for closing remarks.

[Alex Braun, VP and Head of Investor Relations at Acumen Pharmaceuticals]

Thanks, Norma. And thanks for everyone for listening today. If you have any further questions, we're always available at the company. Please reach out. All right. Have a great day.

[Operator]

This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.

Participants

Executives

• Alex Braun, VP and Head of Investor Relations
• Daniel O'Connell, President and CEO
• Eric Siemers, CMO
• Matt Zuga, CFO and CBO

Analysts

• Jason Zemansky, Managing Director at Bank of America
• Samantha Schaeffer, Biotech Equity Research Associate at Cantor Fitzgerald
• Tom Schrader, Managing Director and Healthcare Analyst at BTIG
• Analyst at Stifel