Delaware
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001-37568
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26-4231384
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(State or Other Jurisdiction
of Incorporation or Organization)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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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
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Results of Operations and Financial Condition
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Item 9.01.
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Financial Statements and Exhibits
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Exhibit
Number
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Description
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99.1
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Press release dated November 1, 2016 announcing financial results for the three months ended September 30, 2016.
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Dated: November 1, 2016
|
Edge Therapeutics, Inc. | ||
By: |
/s/ Andrew J. Einhorn
|
||
Name: Andrew J. Einhorn
|
|||
Title: Chief Financial Officer
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Exhibit
Number |
Description
|
|
|
Press release dated November 1, 2016 announcing financial results for the three months ended September 30, 2016.
|
· |
In July, Edge initiated the pivotal Phase 3 NEWTON 2 (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study of EG-1962 administered through an existing external ventricular drain (EVD) in adults who suffer an aSAH resulting from a ruptured brain aneurysm. For information on NEWTON 2, including a list of study sites, please visit clinicaltrials.gov and enter the identifier NCT02790632.
|
· |
In August, Edge closed a $20 million dual-tranche term loan with Hercules Capital, Inc. At closing, $15 million was drawn down with an additional $5 million available to be drawn down at Edge's option until June 2017. Proceeds from the term loan refinanced existing debt and will be used for general corporate purposes.
|
· |
In September, Edge announced additional positive pharmacokinetic data from the Phase 1/2 NEWTON North American study of EG-1962 that supports the potential clinical and health economic impact of EG-1962 in aSAH.
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· |
In October, Edge appointed Dan Brennan, a proven and respected commercial leader in the biopharmaceutical industry, to the newly created position of Chief Operating Officer.
|
· |
In the third quarter, Edge began screening patients in a multi-center, randomized, controlled, open-label study of intracisternal administration of EG-1962 in adults with aSAH. This study will investigate the safety and pharmacokinetic profile of EG-1962 administered directly into the basal cisterns of the brain compared to standard of care oral nimodipine in a group of 12 patients with aSAH. Clinical outcomes will be assessed, as well.
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Three Months Ended September 30,
|
Nine Months Ended September 30,
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|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
6,724,503
|
$
|
6,507,972
|
$
|
18,046,572
|
$
|
12,574,455
|
||||||||
General and administrative expenses
|
3,552,289
|
1,976,888
|
10,526,775
|
5,052,983
|
||||||||||||
Total operating expenses
|
10,276,792
|
8,484,860
|
28,573,347
|
17,627,438
|
||||||||||||
Loss from operations
|
(10,276,792
|
)
|
(8,484,860
|
)
|
(28,573,347
|
)
|
(17,627,438
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Warrant remeasurement
|
-
|
(1,433,502
|
)
|
-
|
(1,879,823
|
)
|
||||||||||
Other expense
|
(163,463
|
)
|
-
|
(163,463
|
)
|
-
|
||||||||||
Interest income
|
56,082
|
1,333
|
148,272
|
2,810
|
||||||||||||
Interest expense
|
(375,089
|
)
|
(213,021
|
)
|
(717,263
|
)
|
(615,047
|
)
|
||||||||
Net loss and comprehensive loss
|
(10,759,262
|
)
|
(10,130,050
|
)
|
(29,305,801
|
)
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(20,119,498
|
)
|
||||||||
Cumulative dividend on Series C , C-1 and C-2 convertible preferred stock
|
-
|
(1,827,568
|
)
|
-
|
(4,257,083
|
)
|
||||||||||
Net loss attributable to common stockholders
|
$
|
(10,759,262
|
)
|
$
|
(11,957,618
|
)
|
$
|
(29,305,801
|
)
|
$
|
(24,376,581
|
)
|
||||
Loss per share attributable to common stockholders basic and diluted
|
$
|
(0.37
|
)
|
$
|
(7.08
|
)
|
$
|
(1.02
|
)
|
$
|
(14.44
|
)
|
||||
Weighted average common shares outstanding basic and diluted
|
28,896,941
|
1,688,475
|
28,848,842
|
1,688,475
|
September 30,
2016
|
December 31,
2015
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
112,784,622
|
$
|
130,189,421
|
||||
Prepaid expenses and other current assets
|
359,863
|
1,081,084
|
||||||
Total current assets
|
113,144,485
|
131,270,505
|
||||||
Property and equipment, net
|
3,291,873
|
2,766,992
|
||||||
Other assets
|
142,870
|
55,161
|
||||||
Total assets
|
$
|
116,579,228
|
$
|
134,092,658
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
LIABILITIES
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
1,963,350
|
$
|
2,584,249
|
||||
Accrued expenses
|
2,290,249
|
3,734,348
|
||||||
Short term debt
|
-
|
2,271,111
|
||||||
Total current liabilities
|
4,253,599
|
8,589,708
|
||||||
|
||||||||
Noncurrent liability:
|
||||||||
Long term debt
|
14,817,482
|
3,025,423
|
||||||
STOCKHOLDERS' EQUITY
|
||||||||
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2016 and December 31, 2015, 28,915,226 shares and 28,810,845 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively
|
9,754
|
9,720
|
||||||
Additional paid-in capital
|
189,058,164
|
184,721,777
|
||||||
Accumulated deficit
|
(91,559,771
|
)
|
(62,253,970
|
)
|
||||
Total stockholders' equity
|
97,508,147
|
122,477,527
|
||||||
Total liabilities and stockholders' equity
|
$
|
116,579,228
|
$
|
134,092,658
|