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.

• The patient journey for anti-amyloid therapies is complex, involving extensive diagnostics, shared decision-making, insurance navigation, and ongoing monitoring, making access and adherence challenging.

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 million cases by 2050, highlighting a growing global burden.

• Neurologists overwhelmingly agree on the high unmet need for additional therapies and expect significant changes in treatment approaches over the next five years.

Evolving role of biomarkers and future clinical practice

• Blood-based biomarkers, especially p-tau217, are expected to become standard for early detection and monitoring, enabling primary care physicians to play a larger role in initial screening and referral.

• Biomarkers are rapidly evolving, with potential for both diagnostic and predictive use, and are simplifying clinical trial enrollment and patient stratification.