Acumen Pharmaceuticals, Inc. is making strides in the development of sabirnetug, a targeted immunotherapy drug candidate aimed at treating Alzheimer's disease (AD). The company's recently released Form 10-Q report for the third quarter of 2024 highlights clinical trial advancements and financial performance.
Clinical Trial Progress
The Phase 2 ALTITUDE-AD clinical trial is currently underway, evaluating the clinical efficacy and safety of sabirnetug in approximately 540 participants with mild cognitive impairment or mild dementia due to Alzheimer's disease. Dosing of the first patient occurred in May 2024, and the company anticipates completing enrollment in the first half of 2025.
Data from the INTERCEPT-AD Phase 1 clinical trial demonstrated that sabirnetug met its primary and secondary objectives. The drug was well-tolerated in early AD patients and exhibited dose-related decreases in amyloid plaque load. This trial also validated a target engagement assay specific to an AβO-targeting antibody.
Subcutaneous Formulation Development
To enhance patient convenience, Acumen Pharmaceuticals has partnered with Halozyme, Inc. to develop a subcutaneous formulation of sabirnetug. A Phase 1 pharmacokinetic (PK) comparison clinical trial has commenced, with the first subject dosed in July 2024. Topline results from this trial are expected in the first quarter of 2025.
Financial Overview
Acumen Pharmaceuticals reported a net loss of $29.8 million for the three months ended September 30, 2024, compared to a net loss of $13.0 million for the same period in 2023. The increase in net loss is primarily attributed to higher research and development expenses. For the nine months ended September 30, 2024, the company's net loss was $65.2 million, up from $35.9 million in the corresponding period of 2023.
Research and development expenses totaled $27.2 million for the three months ended September 30, 2024, an increase of $16.0 million compared to the same period in 2023. This increase reflects the costs associated with the Phase 2 ALTITUDE-AD clinical trial and higher personnel costs, including non-cash stock compensation expenses.
As of September 30, 2024, Acumen Pharmaceuticals had cash and cash equivalents and marketable securities totaling $258.9 million. The company believes that its existing financial resources will be sufficient to fund operating expenses and capital expenditure requirements into the first half of 2027.
Strategic Initiatives and Challenges
Acumen Pharmaceuticals is focused on advancing sabirnetug through clinical trials and expanding its product candidate portfolio. The company amended the ALTITUDE-AD clinical trial protocol from a Phase 2/3 study to a Phase 2 standalone study based on regulatory feedback from the European Medicines Agency (EMA).
The company acknowledges several challenges and risks, including clinical development and regulatory risks, financial risks, market and economic risks, operational risks, strategic risks, and intellectual property risks. To mitigate these risks, Acumen plans to finance its operations through a combination of public or private equity offerings, debt financings, and potential collaboration agreements.
