ABOS - NASDAQ

Hello, and thank you for standing by. Welcome to Acumen Pharmaceuticals Q2 2024 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. [Operator Instructions]. I would now like to turn the call over to Alex Braun, Head of Investor Relations. Please go ahead.

Thank you, operator. Good morning and welcome to the Acumen conference call to discuss our business update and financial results for the quarter-ended June 30, 2024. With me today are Dan O’Connell, our CEO; and Matt

Thanks Dan. As a reminder, our second 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 June 30, we had approximately $281 million in cash and marketable securities on our balance sheet and continue to expect the cash runway to last into the first half of 2027. R&D expenses were $19.5 million in the second quarter. The increase over the prior year was primarily due to the increased spending to support the ALTITUDE-AD trial. G&A expenses were $4.8 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 $24.4 million in the quarter. I'm very pleased with our clinical execution thus far in 2024. We are well resourced to support our Phase 2 study and to develop a subcutaneous formulation of sabirnetug, and are committed to delivering on the opportunity ahead of us for the benefit of patients, caregivers and shareholders. And with that, we can open the call for Q&A. Operator.

Thank you. [Operator Instructions] Our first question comes from the line of Tom Shrader with BTIG. Your line is open.

Okay. All right. Thank you.

Maybe I’ll just add a little bit to that. Yeah, the rate at which we're seeing patients really exceeds our projections and expectations, which is great. You might ask yourself why that might be. As Dan mentioned, it's probably multifactorial, but I think partly it's the strength of our Phase 1 data that was done in patients. We've seen a lot of biomarker changes that are really encouraging for the drug. Secondly, what we've heard from the sites is that they do like the protocol design. It's a Phase 2 study, but really it's like a small Phase 3 study, with an open label extension in the sites like that. We started the study in the U.S. and that's where currently we have most of our patients, but now we're adding sites. We've already added sites in Canada, the UK, and then Europe. So we'll be enrolling more patients in those other geographies.

Okay. Great. Thank you.

Thank you. Please stand by for our next question. Our next question comes from the line of Jason

Thank you. Please stand by for our next question. Our next question comes from the line of Paul Matias with Stifel. Your line is open.

Thank you.

Thank you. Please stand by for our next question. Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald. Your line is open.

And maybe just to add to that a little bit, Samantha. This is Jim. I think part of the reason we're investing so much in both imaging and fluid-based biomarkers in the ALTITUDE study, is that the space is still evolving and understanding exactly what the diversity is amongst patient populations. And so I think as Eric's pointing out, we're very intentionally targeting the early Alzheimer's space. But I think as our understanding is, the field grows in this area, Acumen is going to be very well positioned to understand the importance of individual biomarkers and how that's going to relate to the emerging understanding around different patient populations. So we think we're in pretty good shape at this point.

Thanks so much.

Thank you. Please stand by for our next question. Our next question comes from the line of Trung with UBS. Your line is open.

Hi guys. Trung Huynh from UBS. Thanks for taking my questions. Just on the subcu administration, I've got a couple on there. So do you have any details on this? Is it an auto-injecture? Can it be done at home or in the hospital? And what's the injection volume that you are using? Just trying to get an idea of the convenience for this product. And then, can you just give us any color on what could be presented in 1Q with this data? In particular, could we see any safety data? Thanks very much.

Thanks very much.

Thank you. [Operator Instructions] Our next question comes from the line of Ananda Ghosh with HC Wainwright. Your line is open.

Yeah, so as far as the pTau217, great question. Intuitively, you would sort of think that, well, this is a form of pTau, so it should correlate with tau PET. As it turns out, it's such a sensitive early marker, it actually tends to correlate with amyloid PET, which is not as sensitive. So what we've actually done in our trial is to use pTau217 as a screening measure for people who go on then to PET or CSF. And what we found is by doing that, we reduced the number of negative PET scans and negative CSF by about 50%. So it seems to be working quite well as a screening procedure, and we actually think that that's something that could play out in clinical practice, that a physician would get some from blood pTau217, and who otherwise would go on to have a negative PET scan. So I think it's a really good biomarker. And I'm sorry, I didn't quite catch your second question.

You know, with the lecanemab long-term study, they are showing that patients have this continued benefit based on their ability to target protofibrils. So what's the read-through with sabirnetug?

Well yeah, so we've followed that very carefully, and there's really interesting data. And I think what the field is learning, and we're learning along with the field, is that if you just look at amyloid based on PET scans, it's a very slow increase once you've reduced the amyloid that's there. But what you also see is that apparently PET scans are not that sensitive, because some of the other pathologies, increases in GFAP, increases in various forms of pTau, those things come back a lot sooner than your PET scan gets worse. And so in our view, that's a good indication that partly because, or maybe because lecanemab targets these protofibrils, that when you stop treatment with it, the pathology comes back relatively quickly, and you don't pick that up just based on an amyloid PET scan. And we think that's completely consistent with our hypothesis of targeting these soluble oligomers.

Got it, thanks. Very interesting.

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back to Alex for closing remarks.

Great. Thanks everyone for joining the call today, and for your interest in the company. Please don't hesitate to reach out to us if you have any follow-up questions, and have a great day!