OREANDA-NEWS. Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced financial results for the second quarter ended June 30, 2016.

“Our late-stage programs gained significant momentum in the second quarter. We completed enrollment in our flagship Phase 3 fibromyalgia trial, AFFIRM, for which we plan to report topline data in September. AFFIRM, which enrolled 519 fibromyalgia patients, is a randomized, double-blind placebo-controlled study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, dosed at bedtime over twelve weeks. Also, during the second quarter, we reported positive results from our Phase 2 AtEase study of TNX-102 SL in military-related PTSD. The data support that TNX-102 SL, 5.6 mg, is an effective and well tolerated dose in this population. These findings support the advancement of TNX-102 SL, 5.6 mg, for PTSD Phase 3 development,” said Seth Lederman, M.D., president and chief executive officer of Tonix. “Our key focus for the third quarter is on our fibromyalgia program, highlighted by the upcoming announcement of topline data from our first Phase 3 AFFIRM study in September, and the ongoing enrollment in our recently initiated second Phase 3 RE-AFFIRM study.”  

Tonix ended the June 30, 2016 quarter with $31.2 million in cash and cash equivalents and marketable securities, as compared to $27.5 million as of March 31, 2016.  During the quarter ended June 30, 2016, Tonix raised approximately $11.8 million in net proceeds from an underwritten offering and through an at-the-market offering. In July 2016, Tonix raised approximately $1.4 million in net proceeds from the fully exercised over-allotment of the underwritten offering.

Recent Clinical Highlights and Upcoming Milestones

TNX-102 SL – Fibromyalgia Program

  • Recently completed the clinical phase of the first Phase 3 AFFIRM study.
  • Scheduled to report topline results from the AFFIRM study in September.
  • Initiated a second Phase 3 RE-AFFIRM clinical study, which is expected to enroll approximately 500 patients at approximately 35 clinical centers in the U.S.
  • Presented encouraging results from a retrospective analysis on the Phase 2b BESTFIT clinical study that demonstrated improvements in multiple domains of fibromyalgia including sleep, pain, and physical function.

Fibromyalgia is a chronic neurobiological disorder that is thought to result from amplified sensory and pain signaling. Fibromyalgia afflicts five to 15 million Americans, and physicians and patients report widespread dissatisfaction with currently marketed products. Common symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.

TNX-102 SL – PTSD Program

  • Presented positive results from the Phase 2 AtEase clinical study demonstrating that a 5.6 mg dose is effective and well tolerated for treating military-related PTSD.
  • AtEase was the first large, multicenter, adequate well-controlled study that showed promising results with an Investigational New Drug to treat military-related PTSD.
  • Phase 3 clinical study, employing a trial design similar to AtEase, is expected to begin enrollment in the first quarter of 2017.

             
PTSD affects approximately 8.5 million Americans and is a chronic and debilitating condition, in which patients experience nightmares and disturbed sleep, and which is associated with depression and suicide. Individuals who suffer from PTSD experience impaired social functioning, occupational disability, intense anxiety and avoidance, emotional numbness, intense guilt or worry, agitation and an overall poor quality of life. PTSD is sometimes associated with substance abuse and unpredictable or violent behaviors, additional reasons that make it a critical public health concern. PTSD can develop from witnessing or experiencing a traumatic event or ordeal in which there was the threat or actual occurrence of grave physical harm.

TNX-102 SL is an Investigational New Drug and has not been approved for any indication.

Second Quarter Financial Results

Tonix reported a net loss of $9.8 million, or $0.50 per share, for the second quarter of 2016 compared to a net loss of $11.8 million, or $0.73 per share, for the second quarter of 2015. Net loss for the three months ended June 30, 2016, excluding non-cash expenditures of $0.8 million, was $9.0 million, as compared to a net loss of $10.6 million, excluding non-cash expenditures of $1.2 million, for the three months ended June 30, 2015. The lower net loss was primarily due to decreased research and development expense for clinical studies and related research, as well as lower general and administrative expense needed to support these and other corporate development activities.

Tonix reported a net loss of $23.8 million, or $1.23 per share, for the six months ended June 30, 2016 compared to a net loss of $21.4 million, or $1.44 per share, for the six months ended June 30, 2015.  Net loss for the six months ended June 30, 2016, excluding non-cash expenditures of $1.7 million, was $22.1 million, as compared to a net loss of $18.8 million, excluding non-cash expenditures of $2.6 million, for the six months ended June 30, 2015. The higher net loss was primarily due to increased research and development expense during the first quarter of 2016 for clinical studies and research related to TNX-102 SL, as well as higher general and administrative expense needed to support these and other corporate development activities.

Cash used in operations was $8.0 million and $23.5 million for the three and six months ended June 30, 2016, respectively, as compared to $9.2 million and $18.3 million for the three and six months ended June 30, 2015, respectively. At June 30, 2016, Tonix’s cash, cash equivalents and marketable securities totaled $31.2 million compared to $43.0 million at December 31, 2015. Management believes that Tonix’s existing funds are sufficient to fund its operating expenses and ongoing clinical trials for at least the next 12 months.

TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)

  Three Months Ended
June 30,		 Six Months Ended
June 30,
    2016     2015     2016     2015  
Costs and expenses        
Research and development $ 7,516   $ 8,871   $ 18,187   $ 15,700  
General and administrative   2,320     2,913     5,663     5,780  
Total costs and expenses   9,836     11,784     23,850     21,480  
Operating loss   (9,836 )   (11,784 )   (23,850 )   (21,480 )
Interest income, net   30     21     68     36  
Net loss $ (9,806 ) $ (11,763 ) $ (23,782 ) $ (21,444 )
Net loss per common share, basic and diluted $ (0.50 ) $ (0.73 ) $ (1.23 ) $ (1.44 )
Weighted average common shares outstanding, basic and diluted   19,736,434     16,137,898     19,311,931     14,923,934  


TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)

  June 30, 2016 December 31, 2015(1)
Assets    
Cash, cash equivalents and marketable securities $ 31,246   $ 43,016  
Prepaid expenses and other current assets   2,414     3,343  
Total current assets   33,660     46,359  
Other non-current assets   658     659  
Total assets $ 34,318   $ 47,018  
     
Liabilities and stockholders' equity    
Total liabilities $ 4,284   $ 6,756  
Stockholders' equity   30,034     40,262  
Total liabilities and stockholders' equity $ 34,318   $ 47,018  

(1) The condensed consolidated balance sheet for the year ended December 31, 2015 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.