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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):
May 23, 2023
TONIX PHARMACEUTICALS HOLDING CORP.
(Exact name of registrant as specified in its charter)
Nevada |
001-36019 |
26-1434750 |
(State or Other Jurisdiction
of Incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
26 Main Street,
Chatham,
New Jersey 07928
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code:
(862)
904-8182
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 |
TNXP |
The
NASDAQ Capital Market |
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 ☐
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. ☐
Item
7.01 |
Regulation
FD Disclosure. |
On May 23, 2023, Tonix Pharmaceuticals Holding Corp. (the
“Company”) announced the discovery by Company scientists of the
isolation and functional characterization of the two mirror image
isomers of racemic tianeptine, which is marketed ex-U.S. as a
treatment for major depressive disorder (“MDD”). A copy of the
press release which discusses this matter is furnished hereto as
Exhibit 99.01, and incorporated herein by reference.
The information in this Item 7.01 of this Current Report on
Form 8-K, including Exhibit 99.01 attached hereto, shall not
be deemed “filed” for purposes of Section 18 of the United States
Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise
subject to the liabilities of that section, nor shall they be
deemed incorporated by reference in any filing under the United
States Securities Act of 1933 or the Exchange Act, except as shall
be expressly set forth by specific reference in such a filing.
On May 23, 2023, the Company announced the discovery by its
scientists of the isolation and functional characterization of the
two mirror image isomers of racemic tianeptine. Company scientists
discovered that the (S)-isomer of tianeptine activates
PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and
is free of µ-opioid receptor activity. In contrast,
(R)-tianeptine activates the µ-opioid receptor and lacks
PPAR-β/δ activity. Based on these discoveries, the Company has
begun pre-clinical development of its (S)-isomer, TNX-4300
(estianeptine) product candidate as a treatment for MDD, bipolar
disorder, Alzheimer’s Disease and Parkinson’s Disease. Based on
this discovery, the Company believes that the (S)-isomer is
responsible for tianeptine’s activity on PPAR-β/δ and restoring
neuroplasticity, and the (R)-isomer for its off-target
activity on the µ-opioid receptor. The scientists isolated and
characterized the (S)-isomer, now known as TNX-4300 and
under development for psychiatric and neurological diseases.
The Company expects that its ongoing work on racemic tianeptine in
depression may inform and potentially accelerate the development of
TNX-4300. Although the dose of tianeptine for treating depression
is well-established from racemic studies, the dose range for
treating neurological diseases is not yet determined. Because
TNX-4300 lacks the µ-opioid receptor activity, such effects will
not limit the dosing of (S)-tianeptine for these other
indications. (S)-tianeptine mimics naturally occurring
polyunsaturated fatty acid ligands in binding PPAR-β/δ and PPAR-γ.
(S)-tianeptine’s activation of nuclear PPAR-β/δ and PPAR-γ
receptors appears to be a more direct mechanism to achieve the goal
of restoring neuronal connectivity than current therapies. The
PPAR-β/δ target is validated by prior work on agonists treating
animal models of neurodegenerative and autoimmune diseases of the
central nervous system and the concept that Alzheimer’s can be
considered a form of diabetes that affects the central nervous
system, or type-III diabetes. Key experiments were performed by
scientists at the Company’s Research and Development Center in
Frederick, Maryland. The Company plans to submit data supporting
tianeptine’s mechanism of action for presentation at upcoming
scientific conferences and for publication in peer reviewed
journals.
Forward- Looking Statements
This Current Report on Form 8-K contains certain forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934 and
Private Securities Litigation Reform Act, as amended, including
those relating to the Company’s product development, clinical
trials, clinical and regulatory timelines, market opportunity,
competitive position, possible or assumed future results of
operations, business strategies, potential growth opportunities and
other statement that are predictive in nature. These
forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets
in which we operate and management’s current beliefs and
assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the
negatives of those terms. These statements relate to future events
or our financial performance and involve known and unknown risks,
uncertainties, and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such factors include those set
forth in the Company’s filings with the SEC. Prospective investors
are cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Item
9.01 |
Financial
Statements and Exhibits. |
(d) |
|
Exhibit
No.
|
|
Description. |
|
|
99.01
104
|
|
Press Release of the Company, dated May 23, 2023
Cover Page Interactive Data File (embedded within the Inline XBRL
document)
|
SIGNATURE
Pursuant to the requirement of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
|
TONIX
PHARMACEUTICALS HOLDING CORP. |
|
|
Date:
May 23, 2023 |
By: |
/s/
Bradley Saenger |
|
|
Bradley
Saenger |
|
Chief
Financial Officer |
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