Actinogen Medical (ACW) Status update summary

Advances in Alzheimer's diagnosis and treatment

• Shift from symptom-based to biological diagnosis using biomarkers like amyloid, tau, and neurodegeneration criteria, with blood-based biomarkers such as p-tau217 and p-tau181 now available and increasingly used in clinical practice.

• Anti-amyloid therapies have shown modest clinical benefits and limited uptake due to safety concerns, monitoring requirements, and logistical challenges, with only a small fraction of eligible patients receiving them.

• Blood-based biomarkers are rapidly evolving, enabling earlier and more accurate diagnosis, and are expected to become standard tools for primary care physicians to identify and refer patients.

• The treatment landscape is moving toward a chronic disease management model, with future therapies likely to involve multiple mechanisms and tailored drug combinations.

• There is a growing consensus that Alzheimer's is a complex disease requiring polypharmacy and individualized approaches, similar to cancer or diabetes care.

Alzheimer's disease landscape and unmet needs

• Over 57 million people worldwide lived with dementia in 2021, with Alzheimer's accounting for 60-70% of cases; projections estimate 139-140 million cases by 2050, highlighting a growing global burden.

• Neurologists overwhelmingly agree on the high unmet need for additional disease-modifying therapies, with 91% indicating this and 86% expecting significant changes in treatment over the next five years.

• Disease-modifying therapies are reshaping treatment, but clinical benefits remain modest and current options are not suitable for all patients.

Desired attributes for future therapies

• Neurologists value therapies that slow or halt disease progression, have favorable safety profiles, are easy to administer, and can complement other treatments.

• Future therapies must deliver meaningful clinical benefit while fitting seamlessly into clinical practice.