Q1 2024 Acumen Pharmaceuticals Inc Earnings Call

Good day, and thank you for standing by and welcome to Acumen Park 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 on your telephone.

We will then hear an automated message advisor in your hands raised to withdraw your question. Please press star. 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 Brown, 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 31st 'twenty 'twenty four.

With me today are Dan O'connell our CEO.

Luca our CFO and Chief business Officer.

They do not have some prepared remarks, and then we'll open the call for questions joining.

Joining for the Q&A session. We also have Dr. Jim Doherty, our president and Chief Development Officer, and Dr. Eric floors that Chief Medical Officer.

Before we begin we encourage listeners to go to the investors section of backend web site 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 our 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 development.

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

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 tracking as we work to establish the therapeutic potential of <unk> as a best in class treatment option for this substantial alzheimers patient population.

He used to say that we were off to a great start with the first patient dosed in our altitude <unk> Phase II study announced just last week.

Altitude is a randomize.

Placebo controlled double blind study with three arms.

Designed to evaluate the clinical efficacy and safety. So prototype with approximately 180 participants per arm for a total of 540 participants.

Which with NCI or mild dementia due to all sorts of disease.

We're 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.

Corona stuff the intercept data package appears to be resonating, particularly the confluence of biomarker improvements we saw in patients after only three doses.

Secondly, the design of the altitude study has been viewed favorably by many investigators and patients because our phase one 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 so bernardo.

Additionally, the open label extension is providing.

Proving to be important to patients in the screening process as it provides for 12 months or so.

Active treatment following the 18 month placebo controlled portion of the study.

Overall I'm extremely pleased with the strong foundation that our team and Shiro partner have built with key trial sites, highlighting the benefits of preparation communication for screening and enrollment efficiency.

In addition, we also recently announced the collaboration agreement with logic for manufacturing of stubborn attempt for clinical development and commercialization should it be approved this.

This is important because it allows us to leverage loans as 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 a subcutaneous formulation of <unk> in mid 2024, we believe a competitive product profile for <unk> 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 subordinate type for the benefit of patients caregivers and shareholders I look forward to updating you as we work to achieve altitude <unk> phase II data that we believe will provide the true value inflection for the Super Hornet tug program.

And with that I'll turn the call over to Matt for the financials.

Matt: Thanks, Dan.

As a reminder, our first quarter 2024 financial results are available in the press release, we issued this morning.

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 <unk> trial.

Matt: G&A expenses were $5 $3 million in the quarter with the increase over the prior year, primarily the result of increased head count.

This led to a loss from operations of $17 $8 million in the quarter.

We are off to a strong start with up to date, we are well capitalized to execute on this study and to Dell and to develop a subcutaneous formulation of <unk>.

We are committed to delivering on the opportunity ahead of us and look forward to providing additional updates this year as we advance the burner tug for the benefit of patients caregivers and shareholders and with that we can open the call for Q&A operator.

Speaker Change: Thank you.

As a reminder to ask a question you will need to press star one on your telephone.

Your question. Please press Star one again, please wait for your name to be announced please standby, while we compile the Q&A roster one moment for your first question. Please.

And our first question will come from the line of Tom Shrader with <unk>. Your line is now open.

Hi, good morning, Thanks for taking the question. The question. So I have a couple of quick ones.

First for Matt its R&D about stable now or are.

Are we expecting it to go up significantly I know you are probably early in enrollment that you probably have some upfront costs, so, whereas R&D now compared to what you expect maybe the next two years.

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

Speaker Change: 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.

That kind of the plan. Thank you.

Thanks, Tom This is Dan I will just quickly comment on that maybe Jim or Eric Mike I kind of I think for US right now I think the important thing is getting healthier.

Dan: The healthy volunteer study up and kind of 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.

The next step for sub Q, but certainly want to get these phase one results in hand as quickly as possible.

And maybe just quickly for.

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.

That plan that designed that completely.

Any means but since it will be in patients than 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.

Okay, great. Thank you.

Thank you one moment for our next question. Please.

Yes.

Our next question will come from the line of Paul Matisse with Stifel. Your line is now open.

Hi, there this is James on for Paul Thanks for taking our question and maybe just a follow up on the sub Q and just curious how you're kind of thinking has evolved.

Thank you can ultimately get to a plaque busting dose with the sub Q or is it <unk> more focused on <unk> just kind of curious what your thoughts are there and then also maybe just quickly just just curious when you think about what you're most interested in the upcoming day nanometer AD com and what you think some of the implement implications maybe for the <unk>.

E beta space. Thanks.

Yeah, well, maybe I'll answer the first one and then pass it over to Dan for the second wind or the others, but anyway for the 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 all of them are target engagement.

It's.

All of them are target engagement is something thats important for this antibody, but having some plant production 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.

Dan: Yeah.

Thanks, Eric and James in terms of the outcome for for the native App I think the.

That session will principally focus on two main.

Concerns that you have to answer is in terms of the treatment duration in the house stratification. So.

It will be important discussions to have sort of in a public forum, but I think they will likely have.

<unk> label on market development, but ultimately we do think that the.

So nathan that likely will be.

<unk>.

And really it will become a commercial market or of a product in the Alzheimers space, which we take as a positive business is still sort of the early days.

Commercial infrastructure build and providing greater access to patients. So it's really it was a bit of a curve ball.

For Lilly, presumably but I think that the outcome should go reasonably well and continue that.

Underpinning the growth of this treatment.

<unk>.

Makes sense. Thanks.

Thank you. Thank you one moment our next question.

Our next question comes from the line of Peter <unk> with Cantor Fitzgerald. Your line is now open.

Samantha Shipper: Hi, This is Samantha shipper on the line for Pete now that you have presented the <unk> at multiple conferences and have extensively socialize. The data. We're curious to hear if you have any updated thoughts on the potential mechanism behind the lack of ARIA E. <unk> homozygotes and observed only be now is it patterns.

By chance or is there a plausible mechanistic reasoning thanks for taking my question.

Samantha Shipper: Yeah.

Speaker Change: Those are really good questions and we've thought about it a lot of course I'm not sure that we havent absolute answer to them.

Speaker Change: The.

The fact that we didn't have any area in the <unk> for homozygous first of all obviously, it's really encouraging for this particular antibody, but mechanistically why that would be.

Speaker Change: Just to speculate we could say not all plaques are exactly the same our antibody is targeting.

Emerge.

Merely with a little bit of plaque reduction where some slight reduction in addition.

I think as we learn more about sort of plaques in general at a biochemical level.

Sure.

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.

At this point, it's all speculation obviously in our phase two study, we're going to be looking really carefully for ARIA.

Speaker Change: Bowie for homozygous.

The question you raised about the fact that the ARIA cases.

We're in women is a really good question and interestingly nobody has asked that before but.

But yes, we've thought about that and again, it's kind of like the lack of ARIA E for homozygous.

It is a small study and that could be by chance the same as with the lack of it in the for 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 are your 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.

Interphase II study, but really good question.

Speaker Change: Very helpful. Thank you so much.

Thank you as a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced.

Our next question comes from the line of Jason <unk> with Bank of America. Your line is now open.

Good morning. Thank you so much for taking our questions and congratulations on the progress Q.

Curious as far as your enrollment expectations to altitude, especially given.

Speaker Change: The availability of Makena map and potentially demand a mab in the future can.

Can you talk a little bit about what you think the implications are in.

Whether or not the available availability of either or both of those.

Antibodies are going to impact what you see and then a follow up if I may.

Yes, Jason Thanks for the question and I think.

Based on the scripted work.

A portion of the call.

Highly encouraged with the early phase of the <unk>.

Altitude study.

Speaker Change: Encouraged at the rate of <unk>.

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 in drawing patients attention to the study.

I think as we will see where we get to that.

The nanometer approval and so forth, but right now we are feeling pretty good about that.

Rate of enrollment in altitude.

Yeah.

Got it and then as far as the subcutaneous formulation goes is there.

Possibility or at least a protocol.

Where you can.

Use.

The.

Healthy volunteer study goes well.

Use that within altitude.

Potentially is there some mechanism that would permit.

That again or would you have to wait for a separate study.

Speaker Change: So I guess I had.

Take that one.

Speaker Change: Yes, and in our case.

<unk>.

Theoretically of course, it would be possible to try to put it into out of the two but I'll just tune in to the phase II study it's designed.

Speaker Change: It's completely designed so I think that would be a challenge logistically to actually do.

Speaker Change: Again, what we will do after our healthy volunteer study.

For the sub Q formulation is moved to patients.

Again, we can do a lot of the same things that we're doing and 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.

Got it. Thank you so much for the color.

Speaker Change: Thank you and this concludes our Q&A portion I'd like to hand, the conference back over to Alex Brown for closing remarks. Thanks.

Alex Braun: Thanks norm.

And thanks for everyone for listening today, if you have any further questions. We're always available on our company. Please reach out alright have a great day. This concludes today's conference call. Thank you for your participation. You may now disconnect everyone have a wonderful day.

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