Synaptogenix Announces FDA Authorization of IND Application for Clinical Trial for Bryostatin-1 in Multiple Sclerosis

Collaborative study will evaluate drug's potential to improve synaptic health and cognitive function in MS patients

NEW YORK, June 26, 2024 /PRNewswire/ -- Synaptogenix, Inc. (NASDAQ:SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced that the Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) application for Bryostatin-1 as a potential treatment for multiple sclerosis (MS).

The fully-funded, open-label clinical trial will be held and managed at Cleveland Clinic Neurological Institute's Mellen Center for Multiple Sclerosis. The study will utilize state-of-the-art 7-tesla (7T) magnetic resonance imaging (MRI) technology to identify biomarkers for evaluating Bryostatin-1's impact on the brain.

Robert Fox, M.D., Vice-Chair for Research, Neurological Institute, Cleveland Clinic, and principal investigator for the Bryostatin-1 trial commented, "Our study will apply state-of-the-art MRI technology together with behavioral and cognitive measures to evaluate treatment with investigational Bryostatin-1. Research and development of this drug could yield potential benefits for patients with MS."

"While cognitive decline is broadly recognized as a prevalent symptom of multiple sclerosis, the mechanisms underlying cognitive impairment remain obscure and inadequately studied in clinical trials," said Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix. "We seek to address this unmet need, with minimal expense, and look forward to launching our effort by enrolling/dosing our first patient in the near future."

Bryostatin-1 is a small molecule that works by activating protein kinase C (PKC) enzymes required for maintaining synapse health and is involved in learning and memory. The therapy may also enhance anti-inflammatory efficacy to prevent degradation of the insulating sheath around nerve fibers.

"Bryostatin-1 has been shown in preclinical studies, through its activation of PKC enzymes, to prevent synapse loss and neuronal death, to ameliorate inflammation, and reduce the onset of neurologic deficits," added Daniel Alkon, M.D., President and Chief Scientific Officer. "These preclinical data suggest that Bryostatin-1 has promising potential as a therapeutic agent for MS and perhaps more so for progressive forms of MS."

With a strong balance sheet including approximately $26.3 million in cash as of March 31, 2024, the Company's Phase 1 MS trial is fully-funded. The Company maintains a relatively low cash burn rate and ample resources to support continued development of Bryostatin-1 for MS and other indications, as well as to pursue research on other innovative assets and/or the potential acquisitions of asset rights.

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. 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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