• Bryostatin-1 benefits in severe Alzheimer's disease patients were statistically significant with respect to placebo at p < 0.007

NEW YORK, Dec. 19, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced that its President and Chief Scientific Officer, Daniel L. Alkon, M.D., was honored by the International Association of Biomedical Sciences for his presentation at the University of Southern California-sponsored IABS Forum-2023, a gathering of world-renowned neuroscientists and academics discussing "New Concepts for the Treatment of Neurodegenerative Disorders."

The award was presented by Giulio Maria Pasinetti, M.D., Ph.D., Saunders Family Chair and Professor of Neurology at the Icahn School of Medicine at Mount Sinai, lead spokesperson for the event. Dr. Alkon was congratulated for his cutting-edge research in drug discovery and recognized for his decades of directing programs on the molecular and structural basis of associative memory at the National Neurologic Institute of the National Institutes of Health (NIH).

Dr. Alkon's presentation, titled "Chronic Alzheimer's Disease (AD) Patients Show Safe, Significant, and Persistent Benefit in 10-Month Bryostatin Trial," explored clinical data from the Company's NIH-sponsored, Phase 2 trial of its lead therapeutic candidate as a treatment for severe AD patients. In the trial, secondary efficacy endpoints were met with statistically significant benefits, p < 0.007, for severe AD patients. No significant cognitive decline was observed throughout the 10-month study, and persistent benefits continued at least 16 weeks beyond the final dosing. 

Dr. Pasinetti commented, "We were thrilled that Dr. Alkon, recognized globally as a pioneer in research on brain-based neural networks, the molecular basis of memory and degenerative brain disorders, was able to join us and present at this conference. Dr. Alkon discussed how, in pre-clinical studies, Bryostatin-1, MW 904, an activator of PKC epsilon – BDNF pathways, demonstrated synaptogenic, anti-apoptotic, anti-amyloid, and anti-tau tangle efficacies…." Dr. Pasinetti noted, Bryostatin-1 has the potential to be a promising new treatment for Alzheimer's disease, with potential efficacy extending beyond chronic management to addressing the underlying neurodegenerative consequences of chronic AD progression.

IABS Forum-2023, held December 7-8, 2023 in Irvine, California, was co-sponsored by the University of Southern California (USC) School of Pharmacy and the International Association of Biomedical Sciences.

About Synaptogenix

Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases. Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease. Preclinical studies have also demonstrated bryostatin's regenerative mechanisms of action for the rare disease Fragile X syndrome, and for other neurodegenerative disorders such as multiple sclerosis, stroke, and traumatic brain injury. The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs. Additional information about Synaptogenix, Inc. may be found on its website: 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 anticipated Phase 1 trial of Bryostatin-1 in multiple sclerosis. 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 the Company 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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