Alzheon, Inc. announced that it will be presenting at the 16thInternational Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD conference) to be held on March 15-20, 2022, in Barcelona, Spain, and the 10th Annual Neurodegenerative Drug Development Summit (NDDS conference) to be held on March 28-30, 2022, in Boston, MA, USA. Alzheon Founder, President & CEO, Dr. Martin Tolar will give a podium presentation at the AD/PD conference on March 17, 2022, at 6:45 p.m. local time or 1:45 p.m. ET. This oral presentation will be included in the Scientific Symposium: APOE Mechanisms and Treatment Strategies and can be accessed through the conference virtual portal or directly onsite.

At the NDDS conference, Dr. John Hey, Chief Scientific Officer of Alzheon and Alzheon CEO, Dr. Martin Tolar will give oral presentations on Tuesday, March 29, 2022, at 12:30 p.m. ET and 4:00 p.m. ET, respectively. The AD/PD conference presentation: Interim Results from Phase 2 Biomarker Study with Oral Anti-Amyloid Agent ALZ-801: Plasma Biomarkers in APOE4 Carriers with Early Alzheimer's Disease, will provide an opportunity to hear from Dr. Tolar, discussing the strategy and path to New Drug Application (NDA) for the ALZ-801 (valiltramiprosate) program, as well as the 6-month interim analysis from Alzheon's Phase 2 biomarker study, and updates on the ongoing pivotal APOLLOE4 Phase 3 trial evaluating ALZ-801 oral tablet in Alzheimer's patients. The NDDS conference will include two presentations from Alzheon: Fluid & Imaging Biomarkers in ALZ-801 Development: A First-in-Class Oral Disease Modifying Agent for Alzheimer's Disease:Dr. Hey will describe the science behind biomarkers in Alzheimer's, their importance in diagnosis and monitoring of therapeutic efficacy, as well as baseline data in APOE4 populations and longitudinal effects on core biomarkers in patients receiving ALZ-801 oral tablet.

ALZ-801 Phase 3 Program: Lessons & the Path Forward in Developing Targeted Therapies for Alzheimer's Disease:Dr. Tolar will discuss the precision medicine approach Alzheon pioneered in Alzheimer's, the novel mechanism of action of ALZ-801 (valiltramiprosate), as well as the development strategy and timeline to NDA of the Phase 3 program in AD. ALZ-801 is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. In mechanism of action studies, ALZ-801 has been shown to fully inhibit the formation of neurotoxic soluble amyloid oligomers at the Phase 3 clinical dose.

ALZ-801 acts through a novel enveloping molecular mechanism of action to fully block formation of neurotoxic soluble amyloid oligomers in the human brain7 associated with the onset of cognitive symptoms and progression of AD.1–4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017. The clinical data for ALZ-801 and Alzheon's safety database indicate a favorable safety profile. The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with the APOE4/4 genotype, with future expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This ongoing study is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with the APOE4/4 genotype, who constitute approximately 15% of Alzheimer's patients. This is a double-blind, randomized trial comparing one dose of oral ALZ-801 to placebo treatment over 78 weeks.