• FDA agreement on regulatory starting materials, clinical trial design, and nonclinical studies required for Xanamem marketing approval
• Streamlined development plan with only one additional pivotal trial using a single 10mg Xanamem dose vs. placebo
• Consistent with regulators' desire to find safer and more effective Alzheimer's therapies

Actinogen Medical has announced the successful conduct of its scheduled Type C meeting (written response) on Alzheimer's disease (AD) with the US Food & Drug Administration (FDA). Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD, including agreement on regulatory starting materials in drug substance synthesis, the design of one additional pivotal clinical trial, and the limited number of ancillary clinical pharmacology trials and nonclinical studies required. Key understandings include the 'regulatory starting materials' for the commercial manufacturing of Xanamem (emestedastat) drug substance, the general design of the interim analysis for the XanaMIA trial, the design of one additional, well-controlled, pivotal (phase 3) trial to support a positive XanaMIA pivotal trial, a single emestedastat dose design (10 mg vs placebo) for the planned pivotal Phase 3 trial, the number of people to be treated with Xanamem to be described in the New Drug Application (NDA), a small number of ancillary clinical pharmacology trials, and nonclinical studies required to further characterize the metabolism and excretion pathways of Xanamem. The outcome reached at this meeting with the FDA's Neurology-I Division represents a major milestone for Actinogen as the Company prepares for the earliest possible NDA submission in the US and submissions to other global regulators.

The Company can now confidently move forward following agreement from the FDA on the planned program for Xanamem in Alzheimer's disease.