Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Enrollment in the ALTITUDE-AD Phase II study is progressing faster than projected, indicating strong interest and positive feedback from investigators.
- Acumen Pharmaceuticals Inc (ABOS, Financial) has established productive relationships with quality trial sites across North America, the UK, and the EU.
- The company has dosed its first subject in a Phase I study of subcutaneous sabirnetug, aiming to offer more flexible and convenient dosing options.
- Strong Phase I data and positive biomarker changes have garnered significant interest and support for sabirnetug's mechanism of action.
- Acumen Pharmaceuticals Inc (ABOS) has a robust cash position with approximately $281 million, providing a cash runway into the first half of 2027.
Negative Points
- R&D expenses increased to $19.5 million in Q2, primarily due to spending on the ALTITUDE-AD trial.
- G&A expenses rose to $4.8 million, driven by increased headcount, contributing to a loss from operations of $24.4 million in the quarter.
- The company faces challenges in the anti-A-beta commercial landscape, including educating physicians, engaging patients, and infrastructure issues.
- The subcutaneous formulation of sabirnetug is still in early stages, with bioavailability and safety data pending.
- The company has not disclosed specific details on dosing frequency and volumes for the subcutaneous formulation, leaving some uncertainty.
Q & A Highlights
Q: I have a question on the Phase II trial and what patients you're getting? What is enrollment like in the US with two approved products? Is it tricky or are patients highly compelled by potential for less ARIA? And I would expect enrollment in Europe, people are very enthusiastic. But are you going to limit or are you going to require some number of US patients?
A: Tom, thanks. Great question. And as I mentioned earlier in the prepared remarks, we are encouraged at the enrollment rate. And to date, it has exceeded our expectations from our original forecast. I think this is a consequence of the unmet need in this population as well as the Phase I data that really underpin the differentiation of sabirnetug. Lastly, the study design itself, the feedback from sites and investigators have been very favorable in that the study incorporates two active doses versus placebo and then an open-label extension. So in terms of choice and participation, we're seeing a lot of demand to participate in the ALTITUDE-AD study and we do anticipate a split between North America and Europe. Can't -- haven't preset those mix, but think we'll have patients covering each of the territories or regions that I mentioned earlier.
Eric Seimers - Acumen Pharmaceuticals Inc - Chief Medical Officer: Maybe I'd just add a little bit to that. Yes, 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, and as Dan mentioned, it's probably multifactorial, but I think partly, it's the strength of our Phase I data that was done in patients. We've seen a lot of biomarker changes that are really encouraging for the drug. And secondly, what we've heard from the sites is that they do like the protocol design. It's a Phase II study, but really, it's like a small Phase III study with an open label extension in the sites like that. We started the study in the US, 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.
Q: In thinking about the anti-A-beta commercial landscape, what do you think have been the major challenges or gating factors? Is it educating physicians, engaging with patients? Or has it been an issue of infrastructure, payer access reimbursement? And then appreciating it's early, but do you see opportunities for sabirnetug to potentially differentiate itself? Or is it more that the broader market needs to finish undergoing maturation itself?
A: Thanks, Cameron. And I think you've listed out the multifactorial sort of issues that are basically inhibiting or at least metering out the ramp and the growth and expansion of these treatments, these first couple of approved products. We think that it's interesting now with Lilly coming into the marketplace, the infrastructure will continue to be built out that awareness around the possibility of seeking treatment. We'll continue to draw more awareness in patients into this new treatment paradigm. There are also, I think, one of the points we've made from the AAIC meeting is that the anticipation of fluid biomarkers, blood-based diagnostics, is likely to impact the growth and expansion of this field. So it is multifactorial. I think there's been good progress made, and they will continue to be the infrastructure rolled out. In terms of sabirnetug and differentiation, we absolutely have high conviction that its mechanism is differentiated. And yet as a consequence of that, has the promise of differentiating either or both on efficacy and safety. And that's really our single focus is to offer early AD patients an improved treatment option in terms of benefit to risk profile. So that's -- I think that addresses most of your questions. I don't know, Jim or Eric, if you have any follow-on comments?
Q: What does the path forward look like for the subcu formulation for sabirnetug, and then would that be assessed in parallel to the intravenous formulation if the Phase I were successful? And then separately on that, what dose could you pursue? And would that enable robust plaque target engagement? Or would that be more of like an oligomer dose? And then if you could provide any additional details for the ALTITUDE-AD interim analysis, that would be great as well.
A: Sure. I want to direct that one to Jim as our lead on development efforts.
James Doherty - Acumen Pharmaceuticals Inc - President, Chief Development Officer: Sure. Happy to take it then. Mark, the answer to your question, I think, we're -- the first up really for the subcutaneous development program is to understand the bioavailability of the subcu version. So that's the goal of the first study here in healthy volunteers is to really align the PK from the subcu administration with the Halozyme formulation with what we're learning from the IV studies from INTERCEPT and ongoing work without the (technical difficulty) AD. I think beyond that, we've had a number of options on how to proceed. I think from the point of view of dosing, the targeting of the dosing is intended to hit the same range that we're targeting with the IV formulation. And the purpose of that, of course, is based on our target engagement data from Phase I. We've got high confidence that we are targeting a range that's having an effect dose dependently on soluble oligomer in the brain, and also as we've demonstrated from INTERCEPT, some evidence for plaque reduction as well. And I think we see these as both effects of sabirnetug. We're focused around the hypothesis that reduction of soluble oligomers is going to be beneficial to synaptic function and to overall cognitive function in AD. And I think no reason to think that will be different for the subcutaneous formulation. So that's sort of where we stand at this point. Our efforts are to complete the ongoing Phase I subcu study by the end of the year. And then we'll -- based on a data-driven analysis, move forward with next steps.
Q: The ALTITUDE-AD study is enrolling patients with early AD. Considering the outcomes from other Abeta antibodies in the subpopulation that showed greater clinical benefit, such as those with low tau versus high tau, how are you thinking about the patient population you would like to ideally enroll? Are you looking to have patients with a higher proportion with specific baseline characteristics like centroid levels, plaque or tau to perhaps increase the likelihood of seeing efficacy signals?
A: Thanks, Samantha. Eric, do you want to take that one?
Eric Seimers - Acumen Pharmaceuticals Inc - Chief Medical Officer: Yes, sure. So yes, great question. We're targeting actually the same patient population that we used for the Phase I study, which is patients with MCI and mild dementia, which is frequently being called early symptomatic Alzheimer's disease now. As you point out, people who have less tau based on other antibodies may have a better risk (technical difficulty) those results carefully. What
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
