Current Report Filing (8-k)
September 13 2021 - 8:06AM
Edgar (US Regulatory)
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2021-09-13
2021-09-13
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September 13 yesw
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):
September 13, 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, NJ 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 September 13, 2021, Tonix Pharmaceuticals
Holding Corp. (the “Company”) issued a press release announcing the results of a pre-Investigational New Drug Application
(“pre-IND”) meeting with the U. S. Food and Drug Administration (“FDA”) for TNX-1800 (recombinant horsepox virus,
live vaccine) as a potential SARS-CoV-2 vaccine to protect against COVID-19. 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 September 13, 2021, the Company
announced that it received the official written response from a pre-IND meeting with the FDA to develop TNX-1800 (as a potential SARS-CoV-2
vaccine to protect against COVID-19. The Company believes written response provides a path to agreements on the design of the Phase 1
study and the overall clinical development plan to qualify TNX-1800 as a vaccine to prevent COVID-19. Based on the response, the Company
expects to begin a Phase 1 study of TNX-1800 for the prevention of COVID-19 in the first half of 2022. This pre-IND meeting demonstrates
concurrence and clear guidance on the proposed manufacturing, nonclinical pharmacology and toxicology studies, and Phase 1 clinical design
for TNX-1800.
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
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Financial Statements and Exhibits.
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(d)
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Exhibit
No.
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Description.
|
|
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99.01
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Press Release of the Company, dated
September 13, 2021
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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.
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TONIX PHARMACEUTICALS HOLDING CORP.
|
|
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Date: September 13, 2021
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By:
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/s/ Bradley Saenger
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|
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Bradley Saenger
|
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Chief Financial Officer
|
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