ABOS - NASDAQ

Good day and thank you for standing by. Welcome to Acumen Pharmaceuticals First Quarter 2024 Conference Call and Webcast. [Operator Instructions] 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.

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

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 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 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. And with that, we can open the call for Q&A. Operator?

[Operator Instructions] And our first question will come from the line of Tom Shrader with BTIG.

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 2 years?

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

Yes. And maybe just quickly, yes, for the first study in healthy volunteers, I think the goal was really just a 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 will 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.

Our next question will come from the line of Paul Matteis with Stifel.

This is James [ph] on for Paul. And maybe just a follow-up on the subcu 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 subcu, or is the subcu more focused on oligomers? Just kind of curious what your thoughts are there. And then also maybe just quickly, just curious when you think about, what you're most interested in, in the upcoming donanemab AdComm and what you think some of the implications may be for the broader Abeta space?

Our next question comes from the line of Pete Stavropoulos with Cantor Fitzgerald.

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

Yes, let me go -- and those are really good questions and we've thought about it 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, 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, with 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 II study, we're going to be looking really carefully for ARIA in APOE4 homozygous. 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 yes, we've thought about that. And again, it's kind of like the lack of ARIA in the E4 homozygous. It is a small study and that could be by chance the same as with the lack in the E4 homozygous. 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 II study but really good question.

[Operator Instructions] Our next question comes from the line of Jason

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?

So I guess I'd take that one. Yes, in our case, theoretically, of course, it would be possible to try to put it into ALTITUDE. But ALTITUDE is a Phase II 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 subcu formulation is moved 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 II ALTITUDE study.

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

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.