Synaptogenix Announces Publication of Peer-Reviewed Scientific Article Evidencing Byrostatin-1's Improved Cognition Over Baseline in Advanced Alzheimer's Disease Patients

NEW YORK, Feb. 1, 2022 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("the Company"), a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced that its peer-reviewed scientific manuscript entitled, "Bryostatin Placebo-Controlled Trials Indicate Cognitive Restoration Above Baseline for Advanced Alzheimer's Disease ("AD") in the Absence of Memantine" was published in the Journal of Alzheimer's Disease. The article documents evidence from two placebo-controlled trials that Bryostatin-1 improved cognition over baseline of advanced AD patients.

"Rigorous statistical analyses, including a pooled testing of identical pre-specified cohorts in two separate trials, revealed highly significant (p<.001) benefit of Bryostatin-1 treatment of AD patients in the absence of the dementia treatment memantine. Blinded placebo controls in these trials allow for the exclusion of the placebo effects that so often accompany early testing of candidate drugs to treat AD," stated Dr. Daniel Alkon, MD, President and Chief Scientific Officer. "Importantly, we believe that the peer-reviewed data in our manuscript has provided additional justification for our continued grant support from the National Institutes of Health ("NIH") for our ongoing Phase 2b clinical trial."

Alan Tuchman, M.D., Chief Executive Officer, commented, "The power of these results, enhanced by appropriate pooling of pre-specified cohorts, provides encouragement that our six-month trial will confirm Bryostatin-1's effective treatment of the underlying degenerative progression of AD – a claim that other therapeutic strategies have struggled to demonstrate to date."

About Synaptogenix, Inc.

Synaptogenix is a clinical-stage biopharmaceutical company discovering restorative, novel therapeutics for patients with life-altering neurodegenerative diseases and developmental disorders. Synaptogenix is currently conducting a National Institutes of Health-supported Phase 2b clinical trial of its lead therapeutic candidate Bryostatin-1 in patients suffering from moderately to severe Alzheimer's disease. In addition to AD, preclinical studies have demonstrated Bryostatin-1's regenerative mechanisms of action for the rare disease Fragile X syndrome, and the U.S. Food and Drug Administration has granted the drug Orphan Drug Designation for this indication. Other potential indications include multiple sclerosis ("MS"), stroke, and traumatic brain injury. Bryostatin has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety database that will further inform clinical trial designs. www.synaptogen.com

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. These forward-looking statements include statements regarding the continued development of use of Bryostatin-1 for Alzheimer's disease, Fragile X, and other cognitive diseases. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. There can be no assurance that the clinical program for Bryostatin-1 will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that Bryostatin-1 will ever receive regulatory approval or be successfully commercialized. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Additional factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, the Company's patent portfolio, the Company's inability to expand its business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of the Company's raw materials, existing or increased competition, stock volatility and illiquidity, and the Company's failure to implement its business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements.

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Robert Weinstein
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Synaptogenix, Inc.
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SOURCE Synaptogenix, Inc.