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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 19, 2023
Synaptogenix, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
001-40458 |
46-1585656 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
1185
Avenue of the Americas, 3rd
Floor
New York, New
York 10036
(Address of principal executive offices and zip code)
Registrant’s telephone number, including
area code: (973) 242-0005
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which
registered |
Common Stock, $0.0001 par value per share |
|
SNPX |
|
The Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company. x
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
On July 19, 2023, Synaptogenix, Inc. issued
a press release announcing its entry into an agreement with Cleveland Clinic to conduct a phase 1 trial of Bryostatin-1 in multiple sclerosis.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
SYNAPTOGENIX,
INC. |
|
|
|
By: |
/s/
Robert Weinstein |
|
Name: Robert Weinstein |
|
Title: Chief Financial Officer |
Dated: July 19, 2023
Exhibit 99.1
Synaptogenix and Cleveland Clinic to Submit
Investigational New Drug (IND) Application to FDA for Clinical Trial of Bryostatin-1 in Multiple Sclerosis
Study will evaluate drug’s potential
neuro-restorative mechanism(s) of action for improving synaptic health and cognitive function in MS patients
NEW YORK -- July 19, 2023 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq:
SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics
for neurodegenerative disorders, today announced that it entered into an agreement with Cleveland Clinic to conduct a phase 1 trial of
Bryostatin-1 in multiple sclerosis (MS). Cleveland Clinic will manage the clinical trial’s implementation, including an Investigational
New Drug (IND) submission to the US Food and Drug Administration and patient enrollment.
“We look forward to working together to explore the safety and
potential activity of Bryostatin-1 on cognitive impairment in multiple sclerosis,” said Robert Fox, MD, Vice-Chair for Research,
Neurological Institute, Cleveland Clinic, and Principal Investigator for the Bryostatin-1 trial. “Cognitive impairment is a major
unmet need in the treatment of people living with MS and we look forward to exploring the potential impact of this investigational drug.”
Dr. Alan Tuchman, Chief Executive Officer of Synaptogenix, added, “We
are moving forward with our clinical development plans for Bryostatin-1 in MS in collaboration with Cleveland Clinic. The planned clinical
trial will be held at Cleveland Clinic Neurological Institute’s Mellen Center for Multiple Sclerosis, one of the largest and
most comprehensive programs for MS care and research worldwide. We do not believe that the elimination of synapses caused by MS has been
addressed by any marketed drugs or drug strategies to date, and we believe this gap in MS treatment options presents a significant opportunity.”
Dr. Tuchman continued, “With approximately $35.8 million in
cash as of March 31, 2023, and a relatively low cash burn rate, Synaptogenix is well-funded with ample resources to continue its development
of Byostatin-1 for MS in collaboration with Cleveland Clinic, including initiation of the upcoming trial anticipated to commence in the
fourth quarter of 2023. As we move forward with this study, we will continue to pursue other potential business endeavors including
the identification of other assets for clinical development.”
Dr. Daniel Alkon, President and Chief Scientific Officer of Synaptogenix,
stated, “Cleveland Clinic, a leading provider of advanced Magnetic Resonance Imaging (MRI) technology for brain imaging, is
collaborating with us to identify a biomarker that will evaluate Bryostatin-1’s impact on the brain. Given the drug’s putative
restorative mechanisms of action, its potential unique ability to drive synaptic formation (regeneration), its anti-inflammatory activity,
and its potential for remyelination (replacement of lost insulating sheath surrounding nerve cells), Bryostatin-1 may improve cognitive
function in MS, and address other primary components of the disease.”
Bryostatin-1 is a small molecule that works by activating protein
kinase C, an enzyme required for maintaining synapse health, and involved in learning and memory. The therapy may
also influence the immune system toward anti-inflammatory efficacy. Preclinical
studies have already demonstrated Bryostatin’s potential to address cognitive impairment in other neurodegenerative disorders
such as Alzheimer’s disease, traumatic brain injury, and Fragile X syndrome. MS may represent a new indication to ameliorate
cognitive impairment.
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.
Contact
800-811-5591
ir@synaptogen.com
v3.23.2
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