Cortexyme is initiating an open-label extension study in the United States for its Phase 2/3 GAIN Trial of COR388 in subjects with mild to moderate Alzheimer's disease (AD). Additionally, the GAIN Trial Data Monitoring Committee recently completed its first planned safety review and recommended continuation of the study as planned. The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is based on a growing body of scientific evidence showing that the pathogen Porphyromonas gingivalis, or P. gingivalis, most commonly associated with chronic periodontal disease, and its secreted proteases called gingipains can infiltrate the brain and cause AD. The randomized, double-blind, placebo-controlled trial is evaluating the efficacy, safety, and tolerability of COR388, Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate AD. The GAIN Trial has been ongoing since the second quarter of 2019, with top-line results expected in the fourth quarter of 2021. Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the United States may be eligible to enroll in the open-label extension study, where they will receive COR388 for an additional 48 weeks. During the open-label extension study, safety will be monitored and additional assessments including cognitive tests will be performed. In Phase 1a/1b testing, Cortexyme previously reported favorable safety, tolerability and pharmacokinetics as well as positive biomarker results demonstrating positive trends in patients with AD.