Release Date: November 12, 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 2 study has progressed faster than expected, with over 75 sites active across North America, the UK, and the EU.
- The company anticipates completing enrollment for the ALTITUDE AD study in the first half of 2025, ahead of schedule.
- Acumen Pharmaceuticals Inc (ABOS, Financial) has a strong cash position with approximately $259 million in cash and marketable securities, expected to last into the first half of 2027.
- The company has established effective collaborations with top trial sites, contributing to a promising enrollment rate and reinforcing interest in sabirnetug.
- The appointment of Dr. Amy Shagerly as Chief Regulatory Officer and Head of Quality brings over 30 years of experience, enhancing the company's regulatory and quality assurance capabilities.
Negative Points
- The company reported a net loss of $29.8 million for the third quarter, reflecting ongoing R&D and operational expenses.
- There is no interim data release planned for the ALTITUDE AD study, which may delay insights into the study's progress until completion.
- The ARIA burden remains a concern, and while sabirnetug is expected to have a lower rate, this needs to be confirmed in the Phase 2 study.
- The company has not yet specified the next steps for the subcutaneous formulation of sabirnetug, pending Phase 1 data results.
- The Alzheimer's treatment field is highly competitive, and while Acumen Pharmaceuticals Inc (ABOS) is positioned well, it faces challenges from other anti-amyloid treatments.
Q & A Highlights
Q: What kind of data can we expect from the subcutaneous study, and how do you plan to incorporate it into future studies?
A: The Phase 1 study is in healthy volunteers, evaluating the pharmacokinetics and bioavailability of subcutaneous administered sabirnetug compared to IV. It's primarily a PK bioavailability study that will inform the next steps for advancing a subcutaneous format. It's too early to specify those next steps until we see the data. - Daniel O'Connell, CEO
Q: For ALTITUDE AD, are you considering an interim look at six months, and will you release blinded ARIA data as you go?
A: We have no plans to look at interim results during the study. We aim to preserve the statistical power and integrity of the study, so we will report data at the end. Regarding ARIA, we can't disclose results until the trial is unblinded. - Daniel O'Connell, CEO; James Doherty, President and Chief Development Officer; Eric Siemers, Chief Medical Officer
Q: Are you confident that you will have enough data to do a pivotal study with subcutaneous administration, or will a Phase 2 be necessary?
A: We need to see the data before predicting the next steps for subcutaneous administration. We anticipate both IV and subcutaneous formats will be available in the future, and we are committed to exploring a subcutaneous version for convenience. It's premature to predict the precise next steps. - Daniel O'Connell, CEO
Q: As Phase 2 ALTITUDE AD progresses, what indicators should investors focus on to ensure everything remains on track?
A: The enrollment rate for ALTITUDE AD has exceeded expectations, with completion anticipated in the first half of 2025. This rapid enrollment is attributed to sabirnetug's profile, Phase 1 results, and the enthusiasm of participants and investigators. - Daniel O'Connell, CEO
Q: How are you approaching the enrollment of early AD patients in ALTITUDE AD, considering findings from other anti-amyloid betas?
A: We target patients with mild cognitive impairment or mild dementia with demonstrated Alzheimer's pathology. We anticipate enrolling patients with relatively low amyloid plaque loads, which aligns with current knowledge and should increase the likelihood of seeing efficacy signals. - Eric Siemers, Chief Medical Officer
Q: Why has the ARIA burden been less with sabirnetug, and how has it impacted clinical study enrollment?
A: Sabirnetug was developed to be more specific for oligomers, leading to lower ARIA rates. Clinicians' approaches to using approved monoclonal antibodies vary, but we believe sabirnetug's lower ARIA rate is beneficial. Management of ARIA is evolving rapidly. - Daniel O'Connell, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
