Cumulus Neuroscience to Join Bio-Hermes 2 Study with Funding from the Innovate UK Small Business Research Initiative (SBRI) Dementia Mission Project

Funded by a nearly £1.2M (~$1.5M USD) award, this research will enable ongoing validation of AccelADx™, a breakthrough screening test for early detection of Alzheimer's dementia.

BELFAST, Northern Ireland and CAMBRIDGE, Mass., July 11, 2024 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, today announced receipt of funding from Innovate UK, the UK's innovation agency, which drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas.

Funded by Innovate UK's Small Business Research Initiative (SBRI), this award is focused on enabling organisations with select novel biomarkers to be evaluated as part of the Global Alzheimer's Platform Foundation (GAP) Bio-Hermes 2 Study. Cumulus will deploy AccelADx in the study, a novel, AI-enabled screening test that detects small, subtle changes in brain waves associated with memory recall. Bio-Hermes 2, which aims to generate data to accelerate the adoption and effective use of biomarkers in the study of Alzheimer's disease, will investigate the relationship of novel biomarkers to the current gold standard diagnosis across an ethnically diverse population of 1,000 participants in the United States, Canada, and Europe. The data collected in Bio-Hermes 2 will provide a rich dataset on the extent to which digital and other biomarkers can substitute for more labor-intensive clinical exams and expensive positron emission tomography (PET) scans. Importantly, Cumulus will gain access to the full Bio-Hermes 2 dataset and regulatory-standard data to enable subsequent submissions.

"The diagnosis of Alzheimer's dementia requires detection of changes in brain biology and memory function. While blood tests are emerging to assess biology, physicians still lack accurate tools for detecting changes in cognition and memory, which directly drive loss of independence and reduced quality of life for patients and their caregivers," said Brian Murphy, PhD, Founder and Chief Scientific Officer of Cumulus. "Existing written and computerised cognitive tests can yield false results if patients are anxious or do not understand the instructions. Our goal is to help patients and physicians more directly with the AccelADx screening test, which is uniquely scalable, complementary to protein markers, and specific to Alzheimer's disease. This Innovate UK SBRI award will allow us to validate how well AccelADx works in a large and diverse group of patients, providing critical data to support regulatory approval."

The Cumulus NeuLogiq™ Platform – which includes a first-in-class FDA-cleared and UKCA-marked dry electrode electroencephalogram (EEG) headset – can track the integrity and connectivity of brain networks. The headset synchronises with tablet-based assessments across multiple domains of brain function for use in-clinic or remotely at-home, allowing for an increased ease-of-use for patients, caregivers, and clinical teams.

"Alzheimer's dementia is a devastating disease for patients and their families, directly affecting almost 60 million people today. This is a global problem that requires a global solution," said Dr. George Stothart, senior lecturer, Department of Psychology, University of Bath, inventor of AccelADx, and Research Fellow at Cumulus. "In many cases, symptoms appear very gradually and can be difficult to detect during the early stages of disease. As a result, many patients miss the opportunity to fully benefit from newer treatments focused on slowing disease progression. Quicker, more accurate ways to diagnose dementia are greatly needed so that patients can get treatments earlier and families have an opportunity to plan for the future. We believe AccelADx has the potential to address this substantial unmet need."

Alzheimer's is a progressive disease that affects brain function, memory, and other cognitive abilities. It is the most common cause of dementia, affecting millions of people worldwide. Symptoms usually develop slowly and worsen over time, including memory loss, confusion, mood swings, changes in behavior and personality, and difficulty with language and communication. Currently, there is no known cure for Alzheimer's. Today, earlier diagnosis can enable patients to make lifestyle changes, including exercising and decreasing alcohol consumption, both of which have been shown to slow disease progression. In the future, having the ability to diagnose patients earlier may expedite enrollment in clinical studies and the identification of new treatments.

Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function. To learn more, visit www.cumulusneuro.com.

About Cumulus Neuroscience
With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing NeuLogiq™, an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care. Designed for and with 10 of the world's leading pharma companies, the platform enables decentralized trials, and is already making a difference in the development of therapies for Alzheimer's Disease, depression, and schizophrenia.

Designed to provide an industry-wide standard for real-world measurement of disease progression, Cumulus combines patented technology, in-house expertise, and key industry partnerships to capture large amounts of real-world, clinical data repeated over time, across multiple behavioral and physiological domains in the patient's home – all with an EEG headset synced to a novel, tablet-based neuro-assessment platform. Together with machine learning (ML) analytics and the world's largest database of annotated, longitudinal, neurofunctional data, Cumulus simplifies and improves the robustness of neuroscience clinical trials to provide the best and most cost-effective assessment of CNS treatment outcomes.

The Company is supported by highly experienced specialized investors, DDF/SV Health Investors, LifeArc and Future Fund, and a world-class Scientific and Technical Advisory Board.

FOR MORE INFORMATION
Julie Dietel
FINN Partners for Cumulus
julie.dietel@finnpartners.com
Tel: 978.502.7705

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