Current Report Filing (8-k)
February 06 2023 - 7:06AM
Edgar (US Regulatory)
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2023-02-06
2023-02-06
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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): February 6, 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 February 6, 2023, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced that the first participant was enrolled in the Phase 2 PREVENTION study of the Company’s
TNX-1900 (intranasal potentiated oxytocin) drug-device combination product candidate for the prevention of migraine headache in chronic
migraineurs. 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 February 6, 2023, the
Company announced that the first participant was enrolled in the Phase 2 PREVENTION study of TNX-1900 for the prevention of
migraine headache in chronic migraineurs. The Company believes that by engaging and activating oxytocin receptors in the trigeminal
ganglia, TNX-1900 has the potential to help those suffering from chronic migraine. The Phase 2 PREVENTION study is a double-blind,
randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-1900 taken prophylactically on a daily
basis to prevent chronic migraine. There are three arms to the study: two treatment regimens of TNX-1900 and one placebo in a 1:1:1 ratio
in a total of 300 participants across approximately 25 U.S. sites. After a four-week Run-In phase to confirm meeting chronic
migraine criteria, there are 12-weeks of a double-blind Treatment phase with study drug, followed by a 2-week safety Follow-up
phase. The primary efficacy endpoint is mean change in the number of migraine headache days between the 28-day Run-In phase and the
last 28-days of the Treatment phase. Key secondary efficacy endpoints include proportion of patients experiencing a greater than 50%
reduction in the number of migraine headache days, mean change in the number of days using migraine abortive medications, and mean
change in a migraine-specific quality of life measure. An interim analysis is expected to be completed after the first 50% of
enrolled patients have completed the study for the purpose of potential sample size re-estimation, currently anticipated in the
fourth quarter of 2023.
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. |
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:
February 6, 2023 |
By:
|
/s/
Bradley Saenger |
|
|
Bradley
Saenger |
|
Chief
Financial Officer |
Tonix Pharmaceuticals (NASDAQ:TNXP)
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