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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 25, 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 25, 2023, Tonix Pharmaceuticals Holding Corp. (the
“Company”) announced a poster presentation (the “Presentation”) at
the 2023 American Society of Clinical Psychopharmacology (“ASCP”)
Annual Meeting being held May 30, 2023 to June 2, 2023. 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 25, 2023, the Company announced that its Chief Medical
Officer, Dr. Gregory Sullivan, M.D., will present the Presentation
at the ASCP Annual Meeting. The Presentation will provide an update
on the status of the Phase 2 UPLIFT study of the Company’s TNX-601
ER* (tianeptine hemioxalate extended-release tablets) product
candidate for the treatment of major depressive disorder (“MDD”).
The Presentation will highlight advances in the understanding of
tianeptine’s mechanism of action and provide new details regarding
the preclinical development of the Company’s (S)-isomer of
tianeptine product candidate, TNX-4300* (estianeptine), for MDD,
Alzheimer’s disease, and Parkinson’s disease. A copy of the
Presentation will be available on the Company’s Tonix website at
www.tonixpharma.com
following the conference.
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 25, 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 25, 2023 |
By: |
/s/
Bradley Saenger |
|
|
Bradley
Saenger |
|
Chief
Financial Officer |
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