NEW YORK, Aug. 8, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) today announced its financial results for the quarter ended June 30, 2014.
"In the second quarter, we continued to successfully execute against our strategic clinical and corporate development plans. Perhaps most significantly, in May we announced the completion of enrollment in our BESTFIT trial, a potentially pivotal clinical study evaluating TNX-102 SL in patients with fibromyalgia. Meeting this milestone keeps us on track to announce top-line data in the fourth quarter of this year," said Seth Lederman, M.D., president and chief executive officer. "Also in the second quarter, the United States Food and Drug Administration (FDA) cleared our Investigational New Drug application for post-traumatic stress disorder (PTSD), allowing us to proceed with our planned Phase 2 study, the AtEase Trial, which will evaluate TNX-102 SL in patients suffering from PTSD. In addition, we appointed key additions to the senior management and core development team. We are well equipped to advance and expand our development programs."
Second Quarter Financial ResultsFor the three months ended June 30, 2014, Tonix reported a net loss of $6.0 million, or $0.61 per share, as compared to a net loss of $2.1 million, or $0.95 per share, for the second quarter of 2013. The increase in net loss is primarily due to an increase in research and development expense. At June 30, 2014, Tonix's cash totaled $43.9 million as compared to $8.2 million at December 31, 2013. This cash balance excludes approximately $7.2 million in net proceeds from the sale of shares of common stock in a registered direct offering that closed in July. Recent Corporate Highlights Fibromyalgia Clinical Program
- Completed Enrollment in BESTFIT Trial of TNX-102 SL for Fibromyalgia
- IND for TNX-102 SL in PTSD Cleared by the FDA
- Chief Medical Officer - Gregory M. Sullivan, M.D.
- Senior Vice President of Clinical Development and Regulatory Affairs - Donald J. Kellerman, Pharm.D.
- Senior Vice President of Commercial Planning and Development - Ronald R. Notvest, Ph.D.
- Completed Registered Direct Offering of $7.8 Million
|TONIX PHARMACEUTICALS HOLDING CORP.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Costs and expenses:|
|Research and development||$4,075||944||7,625||1,685|
|General and administrative||1,974||1,142||3,593||2,402|
|Total operating expenses||6,049||2,086||11,218||4,087|
|Interest and other financing costs, net||5||--||10||--|
|Net loss per common share - basic and diluted||$(0.61)||(0.95)||(1.20)||(1.88)|
|Weighted average common shares outstanding - basic and diluted||9,923,184||2,186,537||9,324,020||2,172,921|
|TONIX PHARMACEUTICALS HOLDING CORP.|
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|June 30,||December 31,|
|Prepaid expenses and other current assets||946||429|
|Total current assets||44,816||8,631|
|Other non-current assets||249||105|
|Liabilities and stockholders' equity|
|Total liabilities and stockholders' equity||$45,065||8,736|
|(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.|
CONTACT: Tonix Pharmaceuticals Holding Corp: Leland Gershell, M.D., Ph.D. Chief Financial Officer (212) 980-9155 x104 firstname.lastname@example.org Public Relations: Dian Griesel Int'l. Susan Forman / Laura Radocaj (212) 825-3210 email@example.com firstname.lastname@example.org
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