Synaptogenix, Inc. announced that it has completed enrolling its target of 100 patients for its ongoing National Institutes of Health ("NIH") sponsored Phase 2b clinical trial of Bryostatin-1 for patients suffering from advanced and moderately severe Alzheimer's disease ("AD"). The company expects to announce topline data from the study during the fourth quarter of 2022. Synaptogenix also reports that the independent Data Safety Monitoring Board ("DSMB") overseeing the trial has confirmed the absence of any drug-related adverse safety issues.

Bryostatin-1 caused highly significant cognitive enhancement (4.0 SIB psychometric score above baseline) for the pre-specified patients who received Bryostatin-1 in the absence of Namenda in the company's two previous, consolidated 3-month pilot trials, recently published in a peer-reviewed article (JAD, 2022) – while the Placebo-treated patients showed no significant benefit. Bryostatin-1 treatment has now been extended to include double the number of doses (N = 14) in the current 6-month, placebo-controlled trial, in which randomized enrollment has been carefully controlled for balanced baselines in the treatment and placebo cohorts. Patients will have been observed for as long as three months after all dosing cessation, given the persistence of benefit for at least 30 days after dosing that was previously observed.