Q3 2024 Acumen Pharmaceuticals Inc Earnings Call
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Speaker Change: Hello, and welcome to Acclimate Pharmaceuticals, Q3, 2024 conference call and webcast.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session.
Speaker Change: I asked the question during the session you will need to press star one on your telephone.
You will then hear an automated message advising your hand is raised to.
Speaker Change: To withdraw your question. Please press star one again.
Speaker Change: I would now like to hand, the conference over to Alex Brown, you may begin.
Alex Brown: Thanks to Wanda Hi, good morning, and welcome to the academic conference call to discuss our business update and financial results for the quarter ended September 30th.
Alex Brown: For.
With me today are Dan O'connell, our CEO and not to do though our CFO and chief business Officer.
Alex Brown: That along with our prepared remarks, well open the call for question.
Alex Brown: Joining me for the Q&A session. We also have Doctor, Jim Doherty, our President and Chief Development Officer, and Doctor, Eric singer, our Chief Medical Officer.
Alex Brown: Before we begin walkers listeners to go to the investors section of the website to find our press release issued this morning, well discuss today.
Alex Brown: Please note that during today's conference call, we may make forward looking statements within the mall.
Alex Brown: Of the federal Securities laws 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.
Alex Brown: 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.
Alex Brown: 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.
Speaker Change: So with that I'll turn the call over to Dan.
Dan: Thanks, Alex Good morning, everyone and thanks for joining us today, the third quarter. It was one of focused execution as we continue to progress our clinical efforts for suburban.
Our next generation a beta ligament targeted antibody for the treatment of early Alzheimer's disease.
Dan: Also two D D. Our phase two study designed to evaluate the clinical efficacy and safety of Subaru.
Dan: And roughly 540 patients with mild cognitive impairment or mild dementia due to Alzheimer's currently has more than 75 sites active and enrolling across North America, the U K and EU.
Dan: A woman in altitude has progressed faster than we expected and we now anticipate completion of enrollment in the first half of 2025.
Dan: We believe the altitude J D enrollment is due to characteristics stemming from <unk> mechanism of action.
Dan: Along with enthusiasm from site investigators that's bolstered by our robust phase one data.
Dan: Furthermore, our team has done well to establish effective collaborations with top trial sites across all three regions.
Dan: These factors have contributed to a promising enrollment rate it reinforced the interest in innovative treatment options and a therapeutic potential Sabrina talk.
Dan: We have also continued to progress our phase one study of subcutaneous suburban site and anticipate the top line results for this study would be available in the first quarter of 2025.
Dan: Once we have the PK results in hand, we will be best positioned to formulate next steps for developing subcutaneous suburban type.
Dan: Moving onto our time at the <unk> meeting in Madrid. It was clear at the meeting that the all centers field is moving ahead on both the clinical and research fronts, particularly with anti a beta disease modifying treatments for ADHD we.
Dan: We see acumen in a strong position to capitalize on this momentum.
Dan: I want to share a couple of key takeaways that underpin how the field is advancing.
Dan: So a new and exciting era.
First blood based Biomarkers were a frequent topic and multiple presentations during the meeting including our own.
Dan: Blood based biomarkers are going to fundamentally enable.
Dan: New innovations in both the clinical research and drug development settings. The Sip.
Dan: That is happening right now.
Dan: Our presentation focused on data from our validated research use plasma offshore tow 217 assay, which we are using to screen potential participants in the ongoing phase II altitude critical trial.
At <unk>, we reported that this pizza hut to 17 enrichment screening approach results in a higher proportion of patients who meet the amyloid pet or CSF based inclusion criteria as compared to our phase one intercept trial, which did not use this approach.
Dan: More of the enrichment approaches, resulting in a more efficient partition participant selection process that reduces unnecessary amyloid pet scans with lumbar puncture proceed procedures among patient people, who are not eligible to continue screening.
Dan: Thus far in the study it has reduced the screening incidence of negative amyloid pet scans by about 50% as compared to our phase one study and contributed to the rapid enrollment.
Dan: Second the first reports of real World real World use of that can be presented from researchers from the U S and Japan, highlighting adoption protocols and feasibility of treatment delivery in a diverse geographies and populations.
Dan: So the currently marketed products have acknowledged limitations and are not.
Dan: All for all patients.
Dan: We support making them available for the right patients and matching the right critical teams.
Further we believe the adoption of anti a beta treatments will continue to grow and ultimately serve as the cornerstone of 80 treatment for the foreseeable future.
In October we hosted a virtual R&D day with members of the acumen team.
Dan: Opinion leaders are saying all summer space. If you haven't had a chance to view the webcast.
Dan: Courage you to watch the replay.
Dan: Our web site.
Dan: It provides a deep dive into the scientific rationale supporting Sabrina <unk> mechanism of action targeting toxic EBITDA like ours, our positive phase one clinical results in the phase III clinical plans for some time to talk.
Dan: Additionally, shifting to the organization just last week, we announced the appointment of Dr. Amy shocks as Chief regulatory officer head of quality Amy.
Dan: Amy brings to acumen over 30 years of experience in regulatory affairs quality assurance and therapeutic development with focus on CNS disorders.
Dan: Given amy's deep expertise and experience in global product development. We are thrilled to have her on board as we further refine our product development strategy ahead of key clinical data for <unk>.
Dan: I'd also like to thank Dr. Janice Hitchcock, who lead our regulatory affairs efforts and its retiring at the end of the year Genesis has been instrumental in building our regulatory infrastructure overseeing our regulatory strategy.
Dan: And then driving Savannah take into the clinic, we wish her the best in her retirement.
Speaker Change: And acumen, we're focused on our strategic goal of advancing the clinical development of Sabrina targeting intelligent and efficient manner. The recent developments in the Alzheimer's field, along with new data and our refined understanding of the disease align with our scientific approach and development strategy.
Speaker Change: I look forward to providing updates as we progress towards phase II data and as we work to confirm <unk> promise as a next generation treatment option with a strong benefit risk profile.
Speaker Change: And with that I'll turn the call over to Matt for the financials.
Matt: Thank you Dan.
Matt: As a reminder, our third quarter 2024 financial results are available in the press release, we issued this morning.
And in our 10-Q, we will file later today.
Matt: As of September 30, we had approximately $259 million in cash and marketable securities on the balance sheet and continue to expect that cash runway to last into the first half of 2027.
R&D expenses were $27 $2 million in the third 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 million in the quarter roughly flat to the same period in the prior year.
Matt: This led to a loss from operations of $32 $3 million and a net loss of $29 $8 million in the quarter.
Our net cash our net cash burn in the quarter was approximately $23 million, which includes the impact of $2 $5 million and net interest income $2 $4 million of noncash stock compensation expense and the impact of expense accruals.
Speaker Change: I am very pleased with our ongoing execution in the third quarter, we have the resources necessary to support our phase II study and advance the subcutaneous formulation of <unk>.
Speaker Change: We are dedicated to capitalizing on the opportunities ahead to benefit patients caregivers and shareholders alike.
Speaker Change: And with that we can open the call for Q&A operator.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and then wait for your name to be announced to withdraw your.
Speaker Change: Your question. Please press star one again please.
Speaker Change: Please stand by while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Paul <unk> with Stifel. Your line is open.
Speaker Change: Hey, it's mark on for Paul Thanks for taking our question just had one on the subcutaneous study so what kind of data can we expect there or any more color and then for next steps how do you plan to potentially incorporate that into future studies. Thank you.
Speaker Change: Yeah, Thanks, Mark so the.
Speaker Change: Phase one study in healthy volunteers and we're evaluating that.
Speaker Change: The kinetics of bioavailability of subcutaneous administered <unk> west with IV. So principally it's a PK bioavailability study that will then help inform what precise next steps, we want to take with advancing a sub Q.
Speaker Change: Format I think.
Speaker Change: A little bit early for us to pre specify what those next steps will be until we see the data. Thanks.
Speaker Change: Thanks.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Speaker Change: Our next question comes from the line of Tom Shrader with <unk>. Your line is open.
Good morning, Thank you for taking some questions.
Speaker Change: For <unk> can you remind us your thoughts on taking an interim look at six months.
Speaker Change: Better than looking at it seems like you should know and similarly, you expect to release at least blinded ARIA data as you go or are we waiting for everything.
Tom: Thanks, Tom Yeah, So let me clarify.
Tom: Have no anticipation of looking at it.
Results in the course of the study reporting out.
Tom: I'm blinded blinded.
Speaker Change: Alright data I think as we.
Speaker Change: Perhaps guided previously that the.
Speaker Change: Interaction that we had with regulatory bodies has led us to run the phase two as as essentially a pivotal study.
Speaker Change: We dropped the notion of using an arms in the interest of preserving the registration eligibility of the study.
Speaker Change: Jim or Eric if you'd care to comment as well.
Speaker Change: Okay.
Speaker Change: Yes, Dan.
Speaker Change: This is Jim as you say I think that.
Speaker Change: What's important to us is preserving the statistical power and integrity in the study and so.
Speaker Change: Given the pace that we've been able to enroll the study.
Speaker Change: And because of the regulatory issues that Dan highlighted we think it is important and most effective to continue.
Speaker Change: Continue to study the completion and readout the data yet.
And just maybe one other quick thing just to emphasize the comment Dan made about ARIA reporting obviously this is an important.
Speaker Change: Finding for subordinate side.
Speaker Change: This is a blinded ongoing trial and.
Speaker Change: We really won't we can't.
Speaker Change: Disclose any results regarding <unk> until the end of the trial one were unblinded and so that's our plan as far as <unk> goes.
Speaker Change: Alright, thank you.
Speaker Change: Question pretty reminder, to the last one or are you confident.
Speaker Change: <unk> becomes a necessity.
Speaker Change: You will have enough data based on your phase two in your phase one for sub Q to do a pivotal with sub Q or do you think it is very likely you'd need phase two with sub Q.
Speaker Change: Again I appreciate it's forward looking.
Speaker Change: Sure Tom So I think we really want to see the phase one data before we predict what the next step will be for sub Q I think.
Speaker Change: We do anticipate that both IV and sub Q formats for this class will be available well into the future we're committed to explore.
Subcutaneous version of subcutaneous some prototypes.
Speaker Change: The purpose of providing potentially more convenient.
Format, but I think precisely what the next study.
Speaker Change: As required to advance the program I think again, it's kind of premature to predict exactly how.
Speaker Change: How we will proceed.
Speaker Change: Fair enough thanks for taking a shot.
Speaker Change: Thank you.
Please standby for our next question.
Speaker Change: Our next question comes from the line of Jason <unk> with Bank.
Speaker Change: Bank of America. Your line is open.
Speaker Change: Hi, This is Cameron goes that go on for Jason.
Speaker Change: And thanks, so much for taking the question so as the phase II altitude gets underway what sort of things are you looking for that with giving you an maybe investors confidence.
The pace of enrollment something else I guess, we're just looking for some potential leading indicators you can focus on to suggest everything remains on track here. Thank you so much.
Yeah sure. So great question, So real quickly I mean, we have as we mentioned earlier on the call.
Speaker Change: All right for altitude the phase two.
Speaker Change: Upwards of 540 patients has progressed far more rapidly than we had anticipated and we now are.
Speaker Change: We're expecting to complete enrollment in the first half of next year 2025, and just to sort of set the timeframe, we announced the first patient enrolled in this study in the second quarter of this year. So.
From our own plan and expectations the enrollment has gone.
Speaker Change: Well and I think we attribute that to kind of the profile should burn a tug the phase one results that sort of establish this proof of mechanism around target engagement of oligomers and a safety profile that.
Speaker Change: Participants.
Investigators five exciting potential.
Speaker Change: Potentially.
Speaker Change: Informing us to burn to talk about the nextgen treatment option for patients.
Speaker Change: Thank you.
Speaker Change: As a reminder, ladies and gentlemen that star one to ask the questions.
Speaker Change: Please standby for our next question.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Our next question comes from the line of Pete <unk> with Cantor Fitzgerald. Your line is open.
Speaker Change: Hi, This is Samantha on line for Pete Thanks for taking our questions. So my first question is regarding enrolling patients.
Speaker Change: Patients into altitude.
Speaker Change: Considering findings from other anti amyloid betas that show greater clinical benefit in specific sub population.
Speaker Change: With high tower low Tao how are you thinking about the patient population you would ideally will enroll into altitude are you looking to have a higher proportion of certain baseline characteristics such as it sounds like clock levels, our towel level to potentially increase the likelihood of seeing efficacy signals.
Speaker Change: If you could provide some color on that that would be fantastic.
Speaker Change: Thanks, Kevin I'm going to direct that question over to Eric.
Speaker Change: Who is best equipped to address the population that we're enrolling in altitude Eddie.
Speaker Change: Yes, Thanks, Dan.
Speaker Change: Great question, and obviously I guess, one that we've spent.
Speaker Change: A lot of time thinking about and talking about.
So we've targeted this patient population for people, who have mild cognitive impairment mci or mild dementia. When you cross that line the dementia.
Speaker Change: With demonstrated Alzheimer's pathology.
Speaker Change: In the case of our study that is based on amyloid pet or CSS.
Speaker Change: We did not have any specific requirement for tau pathology.
Speaker Change: Although as you know the field is watching that carefully.
Speaker Change: One of the major things that we talked about was that.
Speaker Change: The data and some of this data is actually very recent would suggest that it's patients who are earlier in.
Speaker Change: The disease course.
Speaker Change: Earlier stage based on Biomarkers and their pathology that have a better response to.
Speaker Change: The drugs that have read out in these larger phase three studies.
Speaker Change: One of the things that we looked at in our phase one study actually is that.
Speaker Change: Our.
Amyloid pet readings were sort of a hybrid between a visual read and just based on an SUV or measure, but the visual reads were important and.
Speaker Change: We did have quite a few of those.
Speaker Change: And what that does is it pushes your average amyloid load your SUV or lower because I think the human eye is just.
Speaker Change: More sensitive than you can pick up people, who are positive, but it wouldn't come across with an SUV or.
Speaker Change: So as these data have emerged and we realize based on our phase one data that using a visual read tends to give you less at least amyloid pathology, we think thats a good thing. So we really feel like from a clinical standpoint, we're doing what is kind of standard in the <unk>.
Now as we identify people with mci or mild dementia, but from a biomarker standpoint, we would anticipate seeing people with relatively low amyloid plaque loads based on their SUV or so obviously, we will get the data at the end of the study, but we think we have.
Speaker Change: Dialed in the inclusion exclusion criteria.
Speaker Change: Now about as well as you can based on the current state of knowledge.
Speaker Change: That's great and one more follow up question on <unk>. If you don't mind, we've actually asked this in the past, but curious to hear your thoughts again on why are your burden has been less so far with the Barnett Hagen, how the RVO burden has impacted clinical study enrollment when speaking to position.
Speaker Change: How do they view our yard.
Speaker Change: Comfortable with administering anti amyloid antibodies or do you think some are still waiting on the sidelines waiting for drugs with lower risk of ARIA.
Speaker Change: Well, yes, another really good question.
Speaker Change: So our premise all along has been because <unk> was developed to be more specific for our commerce and less <unk>.
Speaker Change: Finding the plaque we really anticipated lower are your rates before we even did our phase one study.
Speaker Change: And so the fact that our phase one study showed relatively low rates of area.
Speaker Change: <unk> was not a surprise to us.
Speaker Change: Obviously phase one study is pretty small we need to replicate that at our phase two study and of course, we're looking at that really carefully.
Speaker Change: In terms of how clinicians are approaching using the approved disease modifying monoclonal antibodies.
Speaker Change: It's really controversial and even if this recent seats at meeting there.
Speaker Change: There was a bit of a debate about.
Speaker Change: If you had people who actually had fatalities.
Speaker Change: Using these drugs how carefully should you think about even starting them at all.
Speaker Change: And I think you will get different answers to that question from different clinicians but.
Speaker Change: It's a rapidly developing area, we think because the <unk> should have a lower rate of argot that by itself is obviously, a good thing, but how people manage it when it does happen is something that.
Speaker Change: <unk> is rapidly evolving over time.
Speaker Change: Really appreciate it thanks.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue I would now like to turn the call back over to Alex for closing remarks.
Alex Brown: Thanks Rhonda.
Alex Brown: Thanks to everyone, who listened in today.
Alex Brown: Any remaining questions always feel free to reach out to us at the company.
Alex Brown: And have a wonderful day.
Alex Brown: Okay.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
Alex Brown: Okay.
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Alex Brown: Okay.
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