Acumen Pharmaceuticals Q2 2024 Financial Results and Business Highlights

Acumen Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on innovative treatments for Alzheimer’s disease (AD), has released its financial results for the second quarter of 2024 and provided key business updates.

CEO Daniel O’Connell expressed satisfaction with the company's progress in 2024, particularly highlighting the active enrollment in the global Phase 2 ALTITUDE-AD study initiated in the spring. This study aims to evaluate the clinical efficacy and safety of sabirnetug (ACU193) in early AD. O’Connell noted the strong interest from both investigators and patients in sabirnetug's mechanism of action, which has led to faster-than-anticipated enrollment.

Additionally, in July 2024, Acumen commenced a Phase 1 pharmacokinetic (PK) comparison study to evaluate subcutaneous administration of sabirnetug. The first subject in this study has been dosed, with topline results expected in the first quarter of 2025. This study aims to compare the PK profiles between subcutaneous and intravenous administrations in healthy volunteers.

The company also showcased further research at the Alzheimer's Association International Conference (AAIC) annual meeting. Presentations included biomarker and target engagement analyses, as well as insights into patient experiences from the Phase 1 INTERCEPT-AD study. Detailed biomarker data supporting sabirnetug’s mechanism of action and methods for detecting levels of sabirnetug in cerebrospinal fluid were among the highlights.

Acumen has scheduled a virtual R&D Day on October 2, 2024, to delve into the scientific rationale, Phase 1 clinical results, and Phase 2 clinical plans for sabirnetug. Details for registration will be shared ahead of the event.

Second Quarter 2024 Financial Results:**

- Cash Balance: As of June 30, 2024, Acumen reported cash, cash equivalents, and marketable securities totaling $281.4 million, down from $306.1 million as of December 31, 2023. The decrease is attributed to funding ongoing operations, with the current cash expected to support activities into the first half of 2027.

- Research and Development (R&D) Expenses: R&D expenses for the quarter were $19.5 million, up from $9.1 million in the same quarter of 2023. The increase is primarily due to higher costs associated with clinical trials, personnel, and other operational activities.

- General and Administrative (G&A) Expenses: G&A expenses were $4.8 million, compared to $4.3 million in the previous year. This rise is mainly due to increased personnel-related costs.

- Loss from Operations: The company reported a loss from operations of $24.4 million for the quarter, higher than the $13.5 million loss in the same period of 2023. The increase is due to rising R&D and G&A expenses.

- Net Loss: The net loss for the three-month period ended June 30, 2024, was $20.5 million, compared to $11.6 million in the corresponding period of 2023.

About Sabirnetug (ACU193):

Sabirnetug is a humanized monoclonal antibody specifically designed to target toxic soluble amyloid beta oligomers (AβOs), believed to be potent neurotoxins contributing to neurodegeneration in Alzheimer's disease. Sabirnetug has received Fast Track designation from the U.S. Food and Drug Administration and is currently under evaluation in a Phase 2 study for early AD.

About ALTITUDE-AD (Phase 2):

Initiated in 2024, this Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. It evaluates the efficacy and safety of sabirnetug infusions in slowing cognitive and functional decline. The study aims to enroll about 540 individuals with early Alzheimer’s disease across the United States, Canada, the UK, and Europe.

About INTERCEPT-AD (Phase 1):

Completed in 2023, this Phase 1 trial was a U.S.-based, multi-center study that assessed the safety, tolerability, and proof of mechanism for sabirnetug in early AD patients. Results showed that sabirnetug was well-tolerated with a favorable safety profile and demonstrated amyloid plaque reduction and effects on synaptic biomarkers.

About Acumen Pharmaceuticals, Inc.:

Acumen Pharmaceuticals is dedicated to developing therapies targeting toxic soluble AβOs for Alzheimer’s disease. With pioneering research, Acumen focuses on its investigational product, sabirnetug, currently in Phase 2 trials following positive Phase 1 results. The company is based in Newton, Mass.

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