Form 8-K Tonix Pharmaceuticals For: Nov 10
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
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Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of report (date of earliest event reported): November 10, 2014
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TONIX PHARMACEUTICALS HOLDING CORP.
(Exact name of registrant as specified in its charter)
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| Nevada | 001-36019 | 26-1434750 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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509 Madison Avenue, Suite 306, New York, New York 10022
(Address of principal executive offices) (Zip Code)
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Registrant’s telephone number, including area code: (212) 980-9155
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Copy of correspondence to:
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Marc J. Ross, Esq.
James M. Turner, Esq.
Sichenzia Ross Friedman Ference LLP
61 Broadway, 32nd Floor
New York, New York 10006
Tel: (212) 930-9700 Fax: (212) 930-9725
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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):
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� 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))
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| Item 2.02 | Results of Operations and Financial Condition. |
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On November 10, 2014, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced its operating results for the third fiscal quarter ended September 30, 2014. 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.
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| Item 9.01 | Financial Statements and Exhibits. |
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| (d) | Exhibits. |
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| 99.01 | Press Release, dated November 10, 2014, issued by Tonix Pharmaceuticals Holding Corp. |
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SIGNATURE
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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:��November 10, 2014 | By: /s/ LELAND GERSHELL |
| � | Leland Gershell |
| � | Chief Financial Officer |
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Exhibit 99.01
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Tonix Pharmaceuticals Reports Third Quarter 2014 Financial Results
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NEW YORK – November 10, 2014 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its financial results for the quarter ended September 30, 2014.
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”In September, we announced preliminary top line results from the Phase 2b BESTFIT study of TNX-102 SL in fibromyalgia. We view TNX-102 SL as a broadly active and well tolerated therapeutic candidate for fibromyalgia, and we look forward to initiating a Phase 3 registration program in the first half of 2015 following communication with the FDA,” said Seth Lederman, M.D., president and chief executive officer. “We expect to announce the start of our Phase 2 AtEase study of TNX-102 SL in post-traumatic stress disorder in the coming weeks. Also, we plan to advance our third clinical program, TNX-201 for episodic tension-type headache, into a Phase 2 trial in the first half of next year.”
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Third Quarter Financial Results
For the three months ended September 30, 2014, Tonix reported a net loss of $7.4 million, or $0.71 per share, as compared to a
net loss of $3.1�million, or $0.87 per share, for the third quarter of 2013. The increase in net loss is primarily due to
an increase in research and development expense. At September 30, 2014, Tonix’s cash totaled $46.2 million as compared to
$8.2 million at December 31, 2013.
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About Tonix Pharmaceuticals Holding Corp.
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Tonix Pharmaceuticals is a clinical-stage company developing first-in-class medicines for common disorders of the central nervous system, including fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache. These disorders are characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. Tonix's lead candidate, TNX-102 SL, is intended to be a first-line treatment for fibromyalgia and for PTSD. A Phase 2b trial of TNX-102 SL in fibromyalgia (BESTFIT) has been completed with an optimal therapeutic dose identified, and Tonix is preparing to initiate a Phase 3 program to support registration. A Phase 2 trial of TNX-102 SL in PTSD (AtEase) is expected to begin in the fourth quarter of 2014. TNX-201 is in development for episodic tension-type headache and is currently being evaluated in a Phase 1 trial. To learn more, please visit www.tonixpharma.com.
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Forward Looking Statements
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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" 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 ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing 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 filed with the SEC on March 28, 2014 and future periodic reports filed with the Securities and Exchange Commission. All of the Company'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.
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TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
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| � | � | Three Months Ended | � | � | Nine Months Ended | � | ||||||||||
| � | � | September 30, | � | � | September 30, | � | ||||||||||
| � | � | 2014 | � | � | 2013 | � | � | 2014 | � | � | 2013 | � | ||||
| Costs and expenses: | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � |
| Research and development | � | $ | 5,217 | � | � | � | 1,637 | � | � | � | 12,842 | � | � | � | 3,322 | � |
| General and administrative | � | � | 2,217 | � | � | � | 1,455 | � | � | � | 5,810 | � | � | � | 3,857 | � |
| Total operating expenses | � | � | 7,434 | � | � | � | 3,092 | � | � | � | 18,652 | � | � | � | 7,179 | � |
| � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � |
| Operating loss | � | � | (7,434 | ) | � | � | (3,092 | ) | � | � | (18,652 | ) | � | � | (7,179 | ) |
| Interest and other financing costs, net | � | � | 15 | � | � | � | 2 | � | � | � | 25 | � | � | � | 2 | � |
| Net loss | � | $ | (7,419 | ) | � | � | (3,090 | ) | � | � | (18,627 | ) | � | � | (7,177 | ) |
| Net loss per common share - basic and diluted | � | $ | (0.71 | ) | � | � | (0.87 | ) | � | � | (1.92 | ) | � | � | (2.73 | ) |
| Weighted average common shares outstanding - basic and diluted | � | � | 10,497 | � | � | � | 3,537 | � | � | � | 9,719 | � | � | � | 2,633 | � |
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TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(Unaudited)
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| � | � | September 30, | � | � | December 31, | � | ||
| � | � | 2014 | � | � | 2013 (1) | � | ||
| Assets | � | � | � | � | � | � | � | � |
| Cash | � | $ | 46,227 | � | � | � | 8,202 | � |
| Prepaid expenses and other current assets | � | � | 699 | � | � | � | 429 | � |
| Total current assets | � | � | 46,926 | � | � | � | 8,631 | � |
| Other non-current assets | � | � | 402 | � | � | � | 105 | � |
| Total assets | � | $ | 47,328 | � | � | � | 8,736 | � |
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| Liabilities and stockholders’ equity | � | � | � | � | � | � | � | � |
| Total liabilities | � | $ | 3,551 | � | � | � | 2,224 | � |
| Stockholders’ equity | � | � | 43,777 | � | � | � | 6,512 | � |
| Total liabilities and stockholders’ equity | � | $ | 47,328 | � | � | � | 8,736 | � |
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| (1) | The condensed consolidated balance sheet for the year ended December 31, 2013 has been derived from the audited financial statements but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. |
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Source: Tonix Pharmaceuticals
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Contacts
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Tonix Pharmaceuticals Holding Corp:
Leland Gershell, M.D., Ph.D.
Chief Financial Officer
(212) 980-9155 x104
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Investor Relations
Martini Communications LLC
Amy Martini
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Public Relations:
Dian Griesel Int’l.
Susan Forman / Laura Radocaj
(212) 825-3210
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