This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Good day, and thank you for standing by. Welcome to Acumen Pharmaceutical's 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 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.
spk00: Thanks, Norma. Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter ended March 31st, 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. 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.
spk04: 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 Subirnatug 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 Subirnatug with approximately 180 participants per arm for a total of 540 participants with NCI or mild dementia due to Alzheimer's disease. We are highly encouraged by the start of the altitude study, which we attribute to a couple of key factors. First, we received positive feedback from site investigators on our phase one intercept results. The thoroughness of the intercept data package appears to be resonating, particularly the confluence of biomarker improvements we saw in patients after only three doses. Second, the design of the altitude study has been viewed favorably by many investigators and patients. Because our phase one oligomer target engagement data was so informative, we are proceeding in phase two with two dose arms that may prove efficacious. So patients have a greater chance of receiving a therapeutically relevant dose level of Subirnatug. Additionally, the open label extension is proving to be important to patients in the screening process as it provides for 12 months of Subirnatug active treatment following the 18-month placebo control portion of the study. 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 Subernatug 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 one study in healthy subjects for subcutaneous formulation of Subirnatug in mid 2024. We believe a competitive product profile for Subirnatug includes a subcutaneous option to offer additional flexibility and convenience for patients and caregivers. We'll provide more information on the plan for that work stream once we have the PK results in hand. We remain committed to delivering on our strategic priority to efficiently and thoughtfully advance the clinical development of Suburnatug for the benefit of patients, caregivers, and shareholders. I look forward to updating you as we work to achieve Altitude AD Phase II data that we believe will provide the true value inflection for the Suburnatug program. And with that, I'll turn the call over to Matt for the financials.
spk05: Thanks, Dan. As a reminder, our first quarter 2024 financial results are available in the press release we issued this morning and in our 10Q we will file later today. As of March 31st, 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. We are well capitalized to execute on the study and to develop a subcutaneous formulation of Suburna Tug. We are committed to delivering on the opportunity ahead of us and look forward to providing additional updates this year as we advance Suburna Tug for the benefit of patients, caregivers, and shareholders. And with that, we can open the call for Q&A. Operator?
spk01: Thank you. As a reminder, to ask your question, you'll need to press star 11 on your telephone. To withdraw your question, please press star 11 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. And our first question will come from the line of Tom Schrader with BTIG. Your line is now open.
spk06: Good morning. Thanks for taking the questions. I have a couple 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?
spk05: It's going to trend up. for the next couple of quarters and then, and then flatten out and then go down. So it's, but if you notice R and D this quarter was more than any quarter that we ever had and it's going to, it's going to keep, it's going to go up and sort of plateau for a couple of quarters and then come down.
spk06: 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.
spk04: Thanks, Tom. This is Dan. I'll just quickly comment on that. Maybe Jim or Eric might care. 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 one results in hand as quickly as possible.
spk07: Yeah, maybe just quickly. Yeah, for the first study in healthy volunteers, I think the goal was really just to match AUC. The next study, which would occur in patients, we haven't... develop that, plan that, design 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.
spk06: Okay, great. Thank you.
spk01: Thank you. One moment for our next question, please. Our next question will come from the line of Paul Matisse with Stifel. Your line is now open.
spk08: 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 your kind of thinking has evolved. You know, do you think you can ultimately get to a plaque-busting dose with the sub-Q or is the sub-Q more focused on the oligomers? Just kind of curious what your thoughts are there. And then also maybe just quickly, just curious what you think about or, you know, what you're most interested in in the upcoming Denanamab adcom and, you know, what you think some of the implications may be for the the broader A-beta space. Thanks.
spk07: 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, you know, it's 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 one study.
spk04: Thanks, Eric. And James, in terms of the outcome for the Nanomab, I think that session will principally focus on two main concerns that the FDA has raised in terms of the treatment duration and the trapped house 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 Donatumab 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 outcome should go reasonably well and continue to underpin the growth of this treatment modality.
spk08: Makes sense. Thanks.
spk01: 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.
spk02: Hi, this is Samantha Schaefer 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.
spk07: Yeah, you want me to go ahead? 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 homozygous, first of all, obviously, it's really encouraging for this particular antibody. But mechanistically, why that would be, you know, just to speculate, we could say, you know, not all plaques are exactly the same. Our antibody is targeting oligomers primarily, you know, 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. Obviously, in our phase two 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's asked it before but um but yeah we've thought about that and again it's it's kind of like the lack of aria in the e4 homozygous you know it is a small study and that could be by chance the same as with the lack in the e4 homozygous but it 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, you know, 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 II study. But really good question.
spk02: Very helpful. Thank you so much.
spk01: Thank you. As a reminder, to ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced. Our next question comes from the line of Jason Zemanski with Bank of America. Your line is now open.
spk03: 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 licanumab and potentially demenumab in the future, can you talk a little bit about what you think the implications are and you know, 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.
spk04: Yeah, Jason, so thanks for the question. And I think, you know, based on the scripted word portion of the call, we were highly encouraged with the early phase of the altitude study and encouraged that 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 one data informing and drawing patients' attention to the study and, you know, because we'll see where we get to as to the NANMAP approval and so forth, but right now we are feeling pretty good about the rate of enrollment and altitude.
spk03: Got it. 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?
spk07: 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, you know, Altitude is a phase two study. It's designed, 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, you know, 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 two altitude study.
spk03: Got it. Thank you so much for the color.
spk01: Thank you. And this concludes our Q&A portion. I'd like to hand the conference back over to Alex Braun for closing remarks.
spk00: 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.
spk01: This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.
Disclaimer