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): March 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):
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 | Other Events. |
On March 29, 2016, Tonix Pharmaceuticals Holding Corp. (the “Company”) issued a press release, in which the Company stated that it anticipated announcing topline results from its Phase 2 AtEase clinical trial of TNX-102 SL for the treatment of post-traumatic stress disorder in the last half of May 2016.
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 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
99.01 | Press Release, dated March 29, 2016, issued by Tonix Pharmaceuticals Holding Corp.* |
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* 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: March 29, 2016 | By: /s/ BRADLEY SAENGER |
Bradley Saenger | |
Chief Financial Officer |
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Exhibit 99.01
Tonix Pharmaceuticals to Present at the 10th Annual BIO Europe Spring Conference
New York, NY – March 29, 2016 – Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) (Tonix), which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced today that Ronald Notvest, Ph.D., MBA, Executive Vice President, Commercial Planning and Development of Tonix, will present at the 10th Annual BIO Europe Spring Conference to be held at the Kistamässan Convention Center in Stockholm, Sweden on Tuesday, April 5, 2016 at 4:45 p.m. CET.
During his presentation, Dr. Notvest will provide a corporate update and an overview of Tonix’s fibromyalgia and PTSD clinical programs. Tonix is currently evaluating TNX-102 SL in a randomized, double-blind, placebo-controlled, 12-week Phase 3 AFFIRM clinical trial in fibromyalgia and a randomized, double-blind, placebo-controlled, registration-quality Phase 2 AtEase clinical trial in military-related PTSD. Tonix expects to report top-line AFFIRM data in the third quarter of 2016 and top-line AtEase data in the last half of May 2016. TNX-102 SL is an Investigational New Drug and has not been approved for any indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing next-generation medicines for common disorders of the central nervous system, including fibromyalgia and post-traumatic stress disorder. These disorders are characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. This press release and further information about Tonix can be found at www.tonixpharma.com.
Safe Harbor / Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our possible need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2016, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.
Contact:
Bradley J. Saenger
Chief Financial Officer
(212) 980-9155 x107
bradley.saenger@tonixpharma.com
Jenene Thomas Communications (investors)
Jenene Thomas
(908) 938-1475
jenene@jenenethomascommunications.com
Dian Griesel Int'l. (media)
Susan Forman / Laura Radocaj
(212) 825-3210
sforman@dgicomm.com
lradocaj@dgicomm.com
Source: Tonix Pharmaceuticals Holding Corp.
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