Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q1 2023 Earnings Call Transcript

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q1 2023 Earnings Call Transcript May 14, 2023

Operator: Good day, and thank you for standing by. Welcome to the Acumen Pharma Q1 2023 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. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to Alex Braun, Head of Investor Relations.

Alex Braun: Thanks, Joe. Good morning, and welcome to the Acumen conference call to discuss our business update and the financial results for the quarter ended March 31, 2023. With me today are Daniel O’Connell, our Chief Executive Officer; Dr. Eric Siemers, our Chief Medical Officer; and Matt Zuga, our Chief Financial Officer and Chief Business Officer. Before we begin, we encourage listeners to go to the Investors section of the Acumen website to find a press release issued this morning and a related slide presentation 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 the accompanying 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. After our prepared remarks, we’ll open the call for Q&A. I’ll turn the call over to Dan.

Daniel O’Connell: Thanks, Alex. Good morning, and thank you, everyone, for joining us today. The first quarter of 2023 marked the completion of enrollment in our Phase I INTERCEPT-AD trial, evaluating ACU193 in early Alzheimer’s patients. The study is near completion with top line results expected in the third quarter. For those of you who may be new to Acumen, our product candidate ACU193, is differentiated from other monoclonal antibodies studied in Alzheimer’s disease based on the high selectivity for A-beta oligomers. Scientific consensus asserts that oligomers are the most toxic form of A-Beta. And once they bind to neurons, they inhibit synaptic function and induce neurodegeneration. We are pleased that our top line results are positioned to provide important clinical proof of mechanism data to our monoclonal antibody developed to selectively target toxic A-Beta oligomers in the effort to develop a next-generation therapeutic for Alzheimer’s patients.

Photo by Julia Zyablova on Unsplash

INTERCEPT-AD will provide valuable information required to finalize the design of our next phase for the program, including dose selection. At present, we have growing confidence that every four-week dosing is a viable scenario for ACU193. In addition, as previously disclosed, preliminary CSF PK data from Cohort 3, our 25-milligram per kilogram single ascending dose cohort showed ACU193 concentrations substantially above reported levels of A-Beta oligomers indicating this may be a dosing option to include in our next study. We continue to prepare for Phase II/III activities in anticipation of successful results from our Phase I study, an end of Phase II meeting with the FDA to discuss the design of the next trial is anticipated to be held in the fourth quarter.

As previously disclosed, the study design incorporates an interim decision to expand the size of the study from Phase II to a Phase III study, which is the most expeditious route to a BLA registration. We, along with the rest of the field, are encouraged by the positive momentum in the evolving Alzheimer’s landscape. We are keen to see upcoming outcomes for lecanemabs Advisory Committee meeting, PDUFA date and any shift in CMS coverage decision, which would increase access and uptake for this therapeutic option for patients. We are also highly interested in digesting the full data set from donanemab’s TRAILBLAZER 2 Phase III study announced last week. We recognize that robust plaque clearance has shown clinical benefit, albeit modest and with safety caveats.

We believe there is potential better option for patients that involve selective targeting of toxic species more closely related to disease pathology and that ACU193 embodies that product profile. We look forward to sharing our INTERCEPT-AD top line data with you in the third quarter of this year, a data set that will be informative from a safety, target engagement and dose ranging perspective. With that, I’ll hand the call over to Dr. Siemers. Eric?

Eric Siemers: Thanks, Dan, and good morning, everyone. We continue to work diligently as we near the finish line of our Phase I trial. As Dan highlighted, the totality of the data from INTERCEPT-AD will be important for choosing doses for subsequent studies of ACU193. This includes data on Safety, CSF PK, and CSF target engagement. As I mentioned on our last call at the end of March, the assay for our target engagement is designed to measure the complex of A-Beta oligomers bound to ACU193, and CSF. We have since run preliminary assay tests using CSF from patients which have increased our confidence that the assay is performing as intended. Recall that oligomer concentrations in CSF are generally reported to be less than 2pM, which means that our target engagement assay must be very sensitive.

We also anticipate announcing exploratory data with our topline results from our Phase I study, including Cogstate computerized cognitive testing as well as arterial spin labeling pull sequences on MRI, which will determine if cerebral blood flow has increased after treatment with ACU193. While these analyses are exploratory and may not result in a clear signal in this small study with a short duration of treatment, these techniques maybe employed in the subsequent larger clinical trial using ACU193. As a reminder, we have included typical clinical measures like the CDR sum of boxes and the ADAS-Cog in our Phase I study. However, because this is a small, short study, it is unlikely that those measures will show a drug effect. During the first quarter, our team also presented a poster at AD/PD in Sweden that demonstrated the utility of a human in vitro model of induced pluripotent stem cell-derived excitatory neurons for a better understanding of which forms of A-beta oligomers contribute to the pathogenesis of AD in the human brain.

This study found that soluble A-beta size may influence synaptic binding, low molecular weight 5-way beta species such as monomers, dimers and trimers, demonstrated the lowest levels of detectable synaptic binding compared to those of mid and high molecular weight defined as greater than 150 kilodaltons. We believe that these research efforts can contribute to the development of next-generation therapies with higher selectivity for toxic soluble amyloid species that are the most relevant to Alzheimer’s type of genesis such as ACU193. Finally, the success of donanemab in the TRAILBLAZER II study announced last week, provides further scientific support for the amyloid beta hypothesis broadly. These results build on the success of lecanemab reported in the Phase III CLARITY trial.

While broadly speaking, these antibodies are both related to the amyloid hypothesis, there are important differences between them. Donanemab targets deposited amyloid plaques and reduces plaque load substantially with dosing every four weeks. Lecanemab targets A-beta protofibrils, but also reduces plaque load with every two-week dosing. The rate of ARIA-E with donanemab in TRAILBLAZER-ALZ 2 was reported to be 24%. While for lecanemab, the rate of ARIA-E was reported to be 12.6%. For both antibodies, about 20% to 25% of ARIA-E cases were symptomatic. We believe that ACU193, targeting oligomers has the potential to have lower rates of ARIA-E with equal or better efficacy compared to donanemab and lecanemab. We applaud the well-run study results from TRAILBLAZER-ALZ 2 in clarity that solidify forward momentum in the field.

While these treatments are a good first generation start, ACU193 may further improve the benefit risk profile of a disease-modifying treatment for patients and families navigating Alzheimer’s disease. And with that, I’ll turn the call over to Matt.

Matt Zuga: Thank you, Eric. Good morning, everyone. As a reminder, our first quarter 2023 financial results are available in the press release we issued this morning and in our 10-Q that will be filed later today. As of March 31, we had approximately $184 million in cash and marketable securities on the balance sheet and continue to expect that cash to last through 2025. R&D expenses were approximately $8.7 million in the first quarter, increase over the prior year was primarily due to the increased activity in the ongoing INTERCEPT-AD trial. G&A expenses were $4.4 million in the quarter, with the increase over the prior year, primarily the result of increased headcount as we built the company to support INTERCEPT-AD. This led to a loss from operations of $13.1 million in the quarter.

We are encouraged to report topline data for INTERCEPT-AD in the third quarter and will remain financially disciplined as we use our capital to advance our clinical program for ACU193, and deliver value to patients and shareholders. And with that, we can open the call for Q&A. Operator?

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Q&A Session

Operator: [Operator Instructions] Our first question — I believe this is James on the phone for Stifel.

Operator: Our next question comes from Tom Shrader with BTIG. Go ahead with your question.

Operator: And now we have Judah Frommer with Credit Suisse. Go ahead with your call.

Operator: Next, we have Colin Bristow with UBS. Colin, go ahead with your question.

Operator: And now it looks to be our last question. And this is from Charlie Yang with BofA. Go ahead with your question.

Operator: I’d now like to turn the call back over to Dan O’Connell.

Daniel O’Connell: Thanks, and thank you, everyone, for joining this morning’s call. We are very much looking forward to sharing the INTERCEPT-AD top line data in the third quarter, data that will be informative on ACU193, as a selective agent neutralizing toxic A-beta oligomers. So thanks again for joining. We look forward to speaking with you again soon.

Operator: Thank you all for your participation in today’s call. This does conclude the program, and you may now disconnect.