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EX-99.01 - EXHIBIT 99.01 - Tonix Pharmaceuticals Holding Corp.s103998_ex99-01.htm

 

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): August 29, 2016

 

 

 

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.)

 

509 Madison Avenue, Suite 306, New York, New York 10022

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (212) 980-9155

 

Copy of correspondence to:

 

Marc J. Ross, Esq.

James M. Turner, Esq.

Sichenzia Ross Friedman Ference LLP

61 Broadway

New York, New York 10006

Tel: (212) 930-9700   Fax: (212) 930-9725

 

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))

 

   

 

  

Item 8.01Other Events.

 

On August 29, 2016, Tonix Pharmaceuticals Holding Corp. (the “Company”) issued a press release announcing that the Company has received the final minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) regarding the Company’s post-traumatic stress disorder (“PTSD”) program. The minutes confirmed the FDA’s acceptance of the Company’s proposed Phase 3 studies and the New Drug Application data package to support the registration of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.

 

A copy of the press release that discusses this matter is filed as Exhibit 99.01 to, and incorporated by reference in, this report. The information in this Current Report is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01Financial Statements and Exhibits.

 

(d)Exhibits.

 

99.01Press release, dated August 29, 2016, issued by Tonix Pharmaceuticals Holding Corp.*

 

 

 

* Furnished herewith.

 

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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.

 

    TONIX PHARMACEUTICALS HOLDING CORP.
       
  Date:  August 29, 2016 By: /s/ BRADLEY SAENGER
    Bradley Saenger
    Chief Financial Officer

 

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