• Phase 2 Bryostatin-1 Severe Cohort secondary and exploratory endpoint data selected by independent committee for presentation

NEW YORK, July 13, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced that an abstract featuring secondary endpoint data of its National Institutes of Health (NIH) sponsored Phase 2 Bryostatin-1 trial was accepted for presentation at the 11th International Brain Research Organization (IBRO) World Congress of Neuroscience to be held in September 2023 in Spain.

In the recently completed Phase 2 clinical trial of Bryostatin-1, two cohorts were studied: a Moderate Cohort, with MMSE* scores of 15-18, and a Severe Cohort, with MMSE scores of 10-14.  All patients were randomized with respect to treatment groups, with safety checked by an independent Data Safety Monitoring Board (DSMB). While Moderate Cohort patients showed no significant benefit, for patients of the Severe Cohort, representing the patient population with the most advanced Alzheimer's disease (AD), nearly all pre-specified secondary endpoints were achieved with statistical significance.  Data also showed statistical significance in exploratory secondary endpoints for this Severe Cohort (MMSE 10-14 stratum), and post hoc analysis was positive. Statistical significance in these analyses was measured by patients' Severe Impairment Battery* (SIB) changes from baseline for the Bryostatin-1 treatment group compared with the placebo group patients.

"We believe that our Phase 2 trial Severe Cohort results provide evidence that Bryostatin-1 can prevent—not only slow—cognitive decline in advanced AD patients. We are encouraged that our abstract detailing this data has appealed to IBRO's standards for the annual World Congress of Neuroscience," said Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix. "As we've stated previously, we are continuing to evaluate the potential acquisition of new assets while also exploring strategic non-dilutive investment partners to facilitate continuing Bryostatin-1 development. Our primary focus continues to be value creation for shareholders through our discovery of restorative, novel therapeutics targeting life-altering neurodegenerative diseases."

Dr. Daniel Alkon, President and Chief Scientific Officer of Synaptogenix, commented: "Our trial data from the Severe Cohort patients support the potential use of Bryostatin-1 to prevent cognitive decline in severe AD patients. As opposed to recently approved Alzheimer's drugs, such as lecanemab, aduhelm, and donanenemab, which focus on early-stage dementia and mild cognitive impairment (MCI) and have been shown to only slow those conditions, we are working in a more severe disease cohort and have developed data that we believe indicates that severe Alzheimer's deterioration can be prevented. If further confirmed, our Bryostatin-1 therapeutic could significantly address a huge unmet medical need to both reduce and potentially prevent the underlying progression of advanced AD, without significant side effects."

"We are pleased that the IBRO World Congress has recognized our findings on the cognitive benefits of Bryostatin-1 for advanced and severe AD patients. By addressing synapse dysfunction, Bryostatin goes to the root of cognitive loss in AD. If future trials confirm that progression is blocked by Bryostatin, these findings could form the basis of new therapeutic treatments," said Dr. George Perry, Synaptogenix Scientific Advisory Board Chairman.   

As of March 31, 2023, Synaptogenix maintains a clean capital structure and strong cash position of $35.8 million.

About the IBRO World Congress

In collaboration with neuroscience societies around the globe, IBRO holds international congresses once every four years to promote the field of neuroscience, increase awareness about neuroscience research and facilitate collaboration between researchers from all over the world. To facilitate the international participation, the Congress venues alternate from region to region.

In 2023, the Spanish Neuroscience Society (SENC, Sociedad Española de Neurociencia) will host the 11th IBRO World Congress of Neuroscience at the Granada Exhibition and Conference Centre (Palacio de Exposiciones y Congresos de Granada) from September 9^th thru 13^th, 2023.

About the Phase 2 Trial of Bryostatin-1

Synaptogenix's 6-month Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study comparing Bryostatin-1 to placebo for long-term efficacy in the treatment of advanced and severe AD in the absence of memantine. While Moderate Cohort patients showed no significant benefit, the data demonstrates that Bryostatin-1-treated patients in the Severe Cohort showed statistically significant improvement of cognitive performance over placebo patients for weeks #13 through #42, with the last dose administered at Week #26.

The study was conducted with financial support from the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both part of the NIH.

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 Phase 2 clinical trial of Bryostatin-1 and further studies, and continued development of use of Bryostatin-1 for AD 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 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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* Mini-Mental State Examination, the most commonly used instrument for screening cognitive function.