Delaware
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001-37568
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26-4231384
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(State or Other Jurisdiction
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(Commission
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(I.R.S. Employer
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of Incorporation or Organization)
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File Number)
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Identification No.)
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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 (17CFR 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)) |
Item 2.02 | Results of Operations and Financial Condition |
Item 9.01. | Financial Statements and Exhibits |
Exhibit
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|
Number
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Description
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99.1
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Press release dated August 3, 2016 announcing financial results for the three months ended June 30, 2016.
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Dated: August 3, 2016
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Edge Therapeutics, Inc.
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|||
By:
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/s/ Andrew J. Einhorn
|
|||
Name:
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Andrew J. Einhorn
|
|||
Title:
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Chief Financial Officer
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Exhibit
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Number
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Description
|
Press release dated August 3, 2016 announcing financial results for the three months ended June 30, 2016.
|
· | 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. |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2016
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2015
|
2016
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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
|
-
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(1,746,334
|
)
|
-
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(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
|
)
|
$
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(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
|
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.
|
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
|