OREANDA-NEWS. Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies for the management of acute, life-threatening conditions, today announced financial results for the three months ended June 30, 2016 and recent highlights.

“Edge has made recent significant clinical and corporate progress on multiple fronts,” said Brian A. Leuthner, Edge’s President and Chief Executive Officer. “Our clinical progress is highlighted by the initiation of our Phase 3 NEWTON 2 study of EG-1962 in aneurysmal subarachnoid hemorrhage. On the financial side, we recently closed a $20 million debt facility, which increases our cash position and provides non-dilutive funding at an attractive cost of capital, enabling us to extend our cash runway in order to execute our growth strategy. We are also continuing to build out our management team with the necessary expertise, experience and leadership to help us advance our promising portfolio of life-saving therapies toward commercialization.”

Recent Highlights

  • In May 2016, the U.S. Food and Drug Administration granted Fast Track designation to EG-1962 for the treatment of subarachnoid hemorrhage.
  • In June 2016, the U.S. Patent and Trademark Office granted a new patent covering the use of EG-1962 administered intraventricularly for the treatment of a delayed complication of a brain injury affecting cerebral blood flow.
  • In June 2016, Harry J. Sacks, M.D., FAAP, was appointed Vice President, Clinical Development, thus expanding the team directing the global strategy, planning and execution of Edge’s clinical studies.
  • In July 2016, the first patient was treated in Edge’s pivotal Phase 3 NEWTON 2 (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) clinical study comparing the efficacy and safety of EG-1962 to standard of care oral nimodipine in adults who suffer an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.
  • In August 2016, Edge closed a $20 million dual-tranche term loan with Hercules Capital, Inc. The term loan will be used to refinance existing debt and for general corporate purposes.

Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2016 were $111.0 million, compared with $130.2 million as of December 31, 2015.

Research & Development (R&D) Expenses:  R&D expenses were $6.0 million for the three months ended June 30, 2016, compared to $3.2 million in the same period in 2015. The increase in R&D expense was primarily due to increased spending on clinical activities, including preparations for the Phase 3 NEWTON 2 study, increased personnel-related costs and other R&D expenses.

General & Administrative (G&A) Expenses: General and administrative expenses were $3.3 million for the three months ended June 30, 2016, compared to $1.8 million in the same period in 2015. The increase in G&A expense was largely due to stock based compensation expenses, personnel-related costs, professional fees and additional expenses to support public company operations.

Net Loss: Net loss was $9.4 million for the three months ended June 30, 2016, compared to net loss of $5.5 million for the same period in 2015.

About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. (Edge) is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening neurological conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm.

EDGE THERAPEUTICS, INC.                
Statements of Operations and Comprehensive Loss                
                 
                 
                 
    Three Months Ended June 30,   Six Months Ended June 30,
      2016       2015       2016       2015  
         
                 
Operating expenses:                
Research and development expenses   $   5,975,306     $   3,195,244     $ 11,322,069     $  6,066,483  
General and administrative expenses       3,288,889         1,765,065         6,974,486         3,076,095  
                 
Total operating expenses     9,264,195         4,960,309       18,296,555         9,142,578  
                 
Loss from operations       (9,264,195 )       (4,960,309 )       (18,296,555 )       (9,142,578 )
                 
Other income (expense):                
Warrant remeasurement       -         (350,129 )       -         (446,321 )
Interest income       49,376         1,338         92,190         1,477  
Interest expense       (161,310 )       (211,863 )       (342,174 )       (402,026 )
                 
Net loss and comprehensive loss       (9,376,129 )       (5,520,963 )       (18,546,539 )       (9,989,448 )
                 
Cumulative dividend on Series C , C-1 and C-2  convertible preferred stock       -         (1,746,334 )       -         (2,429,515 )
                 
Net loss attributable to common stockholders   $ (9,376,129 )   $ (7,267,297 )   $ (18,546,539 )   $ (12,418,963 )
                 
Loss per share attributable to common stockholders                
  basic and diluted   $   (0.33 )   $    (4.30 )   $   (0.64 )   $   (7.36 )
                 
Weighted average common shares outstanding basic and diluted       28,828,449         1,688,475         28,820,678         1,688,475  
                 
EDGE THERAPEUTICS, INC.        
Balance Sheets        
         
    June 30,   December 31,
      2016       2015  
ASSETS   (unaudited)    
Current assets:        
Cash and cash equivalents   $ 111,022,034     $ 130,189,421  
Prepaid expenses and other current assets     793,808       1,081,084  
Total current assets     111,815,842       131,270,505  
         
Property and equipment, net     3,461,121       2,766,992  
Other assets     142,870       55,161  
         
Total assets   $ 115,419,833     $ 134,092,658  
         
LIABILITIES AND STOCKHOLDERS'  EQUITY        
LIABILITIES        
Current liabilities:        
Accounts payable   $ 2,854,796     $ 2,584,249  
Accrued expenses     1,519,909       3,734,348  
Short term debt     2,389,222       2,271,111  
Total current liabilities     6,763,927       8,589,708  
         
Noncurrent liability:        
Long term debt     1,899,802       3,025,423  
         
         
STOCKHOLDERS'  EQUITY        
Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2016        
and December 31, 2015, 28,849,446 shares and 28,810,845 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively.        
at June 30, 2016 and  December 31, 2015, respectively     9,733       9,720  
Additional paid-in capital     187,546,880       184,721,777  
Accumulated deficit     (80,800,509 )     (62,253,970 )
Total stockholders' equity     106,756,104       122,477,527  
         
Total liabilities and stockholders' equity   $ 115,419,833     $ 134,092,658