• Announces encouraging secondary endpoint results from NIH-sponsored Phase 2 clinical trial of Bryostatin-1 in advanced Alzheimer's disease patients
• Maintains strong financial position with approximately $37.5 million in cash as of December 31, 2022
• Exploring opportunities which may include acquiring rights to new assets; continuing collaborative research with strategic partners

NEW YORK, March 7, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today provided a corporate update and announced encouraging results of its analysis of secondary endpoints and post hoc analysis from its National Institute of Health ("NIH") - sponsored Phase 2 extended clinical trial evaluating the safety, tolerability, and long-term efficacy of Bryostatin-1 for the treatment of advanced Alzheimer's disease (AD).

Dr. Alan Tuchman, Synaptogenix Chief Executive Officer, stated, "Senior management and our Board of Directors have concluded an exploratory review of our business operations. With encouraging results from our secondary, exploratory, and post hoc analysis of our Phase 2 Bryostatin-1 trial results, we are continuing to evaluate next steps and will seek a validating third party strategic and non-dilutive investment partner to move forward with that program. In the meantime, we continue to evaluate the use of Bryostatin-1 with our previously announced strategic partners for additional indications, Cleveland Clinic and Nemours A.I. DuPont Hospital. Additionally, Synaptogenix remains well-funded with approximately $37.5 million in cash as of year-end 2022 and a relatively low cash burn rate, which could support a potential acquisition of asset rights or funding trials for other assets. As we evaluate these business opportunities, our primary focus is creating shareholder value, and we look forward to updating our investors on our new initiatives in the near term."   

Phase 2 Bryostatin-1 Trial: Secondary and Exploratory Endpoints, Post Hoc Analysis

Synaptogenix Scientific Advisory Board Chair Dr. George Perry commented, "The secondary endpoints, together with post hoc analysis of this trial and the results of the previous trials, show material consistency in the MMSE-2 10-14 stratum, indicating that there may be continued promise for the use of Bryostatin-1 for the segment of the Alzheimer's patient population with the most advanced cases of the disease."

As previously announced, the Phase 2 Bryostatin-1 trial's primary endpoint of change from baseline in the SIB (Severe Impairment Battery) total score assessment obtained after completion of the second course of treatment (week 28) was not met with statistical significance. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints* were met with statistical significance in the low-to-moderately severe AD patient stratum. However, nearly all pre-specified secondary endpoints in the most advanced and severe AD (MMSE: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = <0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive. 

Secondary efficacy endpoints met with statistical significance (MMSE-2 10-14 stratum):

• Changes from baseline at weeks 20, 24, and 30 in the SIB total score.

Exploratory endpoint met with statistical significance (MMSE-2 10-14 stratum):

• Change from baseline in MMSE-2 total score at week 42.

Post hoc analysis:

• Treatment differences from the baseline SIB total score for the MMSE-2 10-14 stratum confirmed statistical significance at weeks 13, 15, 28, and 42 using Bryostatin-1.
• Trend analysis of the MMSE-2 10-14 stratum was also statistically significant.

"Our latest statistically significant results for the severe AD patient stratum (MMSE 10 -14) reinforce the observed clinical benefit for this same severe stratum in our two previous, shorter duration Phase 2 Bryostatin-1 trials. I believe these data provide promising evidence that Bryostatin-1 can prevent – not only slow – cognitive decline in advanced AD patients," stated Dr. Daniel Alkon, President and Chief Scientific Officer.

About the NIH-Sponsored Phase 2 Clinical Trial

The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study comparing 6 months' Bryostatin-1 to placebo for long-term efficacy in the treatment of advanced and moderately severe AD in the absence of memantine. The study was conducted with financial support from the National Institute on Aging (NIA) and the National Cancer Institute (NCI), both part of the National Institutes of Health (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.

* MMSE-2 scores of 10-14 and 15-18 were the only pre-specified secondary analysis of the separate MMSE strata in the trial.

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