CHARLOTTESVILLE, Va. and CARMEL, Ind., March 27, 2023 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company focused on developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) and is designed for the treatment of Alzheimer’s disease (AD), today reported financial results for the full year ended December 31, 2022 and provided a business update.
“2022 was a year of significant accomplishment as we advanced the clinical development of ACU193, our novel therapeutic targeting toxic amyloid beta oligomers for the treatment of Alzheimer’s Disease. We recently completed enrollment in our Phase I INTERCEPT-AD trial and are encouraged by preliminary pharmacokinetic and safety data that support ACU193’s differentiated product profile,” said Daniel O’Connell, President and Chief Executive Officer of Acumen. “We believe that our continued execution will drive Acumen’s momentum during 2023. Our Phase 1 topline results expected in the third quarter and anticipated interaction with FDA in the fourth quarter of 2023 will help inform our next phase of clinical development. With cash runway expected through 2025, a strong scientific foundation, and an increasingly attractive market environment, we believe we are well positioned to achieve our near-term milestones and to advance our mission of delivering a novel treatment option for patients with Alzheimer’s Disease.”
Recent Business Highlights and Anticipated Milestones
ACU193 Clinical Development
- In October 2022, Fast Track designation was granted by the U.S. Food and Drug Administration (FDA) for ACU193 for the treatment of early Alzheimer’s disease. Fast Track designation is granted to drugs being developed for the treatment of serious or life-threatening conditions where there is an unmet medical need. Fast Track designation does not change the standard for approval, but a drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process for the purpose of expediting the drug’s development, review, and potential approval.
- In January 2023, a protocol amendment was submitted to the FDA with respect to Cohort 7 of the Company’s Phase 1 INTERCEPT-AD clinical trial to reduce the dose to 25 mg/kg every two weeks (updated from 60 mg/kg every two weeks). The change was based in part on a blinded review of preliminary pharmacokinetic data in the trial, inclusive of levels of ACU193 in plasma and cerebrospinal fluid, which indicated a dose of 60 mg/kg every two weeks should not be needed to attain central target engagement, and preliminary safety data, including two asymptomatic cases of ARIA-E (one in Cohort 4 after a single 60 mg/kg dose and one in Cohort 5 after the third 10 mg/kg dose).
- In February 2023, enrollment was completed in the Company’s Phase 1 INTERCEPT-AD trial of ACU193 in patients with early Alzheimer’s disease.
- Acumen anticipates reporting topline results from this trial, including safety and proof-of-mechanism data, in the third quarter of 2023.
Corporate
- In 2022, we continued to expand our team with talent necessary to advance our mission to develop a novel treatment for AD. These appointments included Liean Schenck, MS as our VP, Head of Chemistry, Manufacturing and Controls (CMC) and Derek Meisner, JD as our Chief Legal Officer.
- In January 2023, Derrell Porter, M.D. joined Acumen’s Board of Directors. Dr. Porter is a physician-entrepreneur with more than 20 years of experience in drug development. He is currently the Founder and CEO of Cellevolve, a development and commercialization company focused on cell therapy, and previously served in commercial and corporate development roles at Atara Biotherapeutics, Inc., Gilead, AbbVie and Amgen.
2022 Financial Results
- Cash Balance. As of December 31, 2022, cash, cash equivalents and marketable securities totaled $193.4 million, compared to cash, cash equivalents and marketable securities of $225.9 million as of December 31, 2021. The decrease in cash is related to funding ongoing operations.
- Research and Development (R&D) Expenses. R&D expenses for 2022 were $32.4 million compared to $12.3 million in 2021. The increase in R&D expenses in 2022 compared to 2021 was primarily due to increased costs related to our ongoing clinical trial, which was initiated in 2021 and started enrolling patients in the second half of 2021, as well as nonclinical research and development activity.
- General and Administrative (G&A) Expenses. G&A expenses for 2022 were $12.9 million, compared to $7.3 million in 2021. The increase in G&A expenses in 2022 compared to 2021 was primarily due to increased expenses as a public company and additions to its financial and administrative infrastructure, such as costs related to personnel, accounting, marketing, recruiting and travel and entertainment expenses.
- Loss from Operations. Losses from operations for 2022 were $45.2 million, compared with $19.6 million in 2021. This increase was due to the increased R&D and G&A expenses over the prior year period.
- Net Loss. Net loss for the year ended December 31, 2022 was $42.9 million, compared to a net loss of $100.6 million for the year ended December 31, 2021. Net loss in 2021 includes a $81.2 million non-cash expense that represents the changes in fair value of Acumen’s Series B tranche liability and Series A-1 warrant liability.
About ACU193
ACU193 is a recombinant humanized immunoglobin gamma 2 (IgG2) monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble AβOs, which Acumen believes are the most toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, ACU193 aims to directly address what a growing body of evidence indicates is a primary underlying cause of the neurodegenerative process in AD. ACU193 has been granted Fast Track designation for the treatment of early Alzheimer’s disease by the U.S. Food and Drug Administration.
About INTERCEPT-AD
INTERCEPT-AD is a Phase 1, U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and tolerability, and establishing clinical proof of mechanism, of ACU193 in patients with early Alzheimer’s disease (AD). Sixty-five individuals with early AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-human study of ACU193. The INTERCEPT-AD study consists of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of ACU193. The study has completed enrollment across multiple investigative sites located in the United States. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA, with clinical operations based in Carmel, IN, is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are primary triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, ACU193, a humanized monoclonal antibody that selectively targets toxic soluble AβOs in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients. For more information, visit www.acumenpharm.com.
