Current Report Filing (8-k)
July 23 2021 - 5:01PM
Edgar (US Regulatory)
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 23, 2021
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 Global 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 July 23, 2021, Tonix Pharmaceuticals
Holding Corp. (the “Company”) issued a press release announcing the outcome of the interim analysis of the Phase 3 RALLY study
for its TNX-102 (cyclobenzaprine HCl sublingual tablets) 5.6 mg product candidate for the management of fibromyalgia (the “RALLY
Study”). A copy of the press release is furnished as Exhibit 99.01 hereto 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 July 23, 2021, the Company
announced that the RALLY Study will stop enrolling new patients due to inadequate separation from placebo at week-14 following an unblinded,
preplanned interim analysis by the Independent Data Monitoring Committee (“IDMC”) of the RALLY Study. Based on interim analysis
results of the first 337 enrolled participants, the IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate
a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between
those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo. The Company remains blinded to the detailed analysis
results and only received the recommendation made by the IDMC. Preliminary blinded safety data from these participants did not reveal
any new safety signals, and the decision to discontinue enrolling new participants is not related to safety. The Company intends to continue
studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data, with topline
results expected to be reported in the fourth quarter of 2021, to determine the next steps in this program.
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 development
of TNX-601 CR, 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
|
|
Press release of the Company,
dated July 23, 2021
|
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:
July 23, 2021
|
By:
|
/s/
Bradley Saenger
|
|
|
|
Bradley Saenger
|
|
|
Chief Financial Officer
|
Tonix Pharmaceuticals (NASDAQ:TNXP)
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