Delaware
|
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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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)
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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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☐ |
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 |
Results of Operations and Financial Condition
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Item 9.01. |
Financial Statements and Exhibits
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Exhibit
Number
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Description
|
99.1
|
Press release dated March 1, 2018 announcing financial results for the three months and full year ended December 31, 2017.
|
Dated: March 1, 2018
|
Edge Therapeutics, Inc.
|
||
By:
|
/s/ Andrew Saik
|
||
Name: Andrew Saik
|
|||
Title: Chief Financial Officer
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Exhibit
Number
|
Description
|
Press release dated March 1, 2018 announcing financial results for the three months and full year ended December 31, 2017.
|
· |
Completed the EG-1962 Phase 3 NEWTON 2 Futility Analysis; Study Continues as Planned. In December 2017, Edge announced that an independent Data Monitoring Committee (DMC) recommended that the Phase 3 NEWTON 2 study of EG-1962 continue as planned based on the completion of a pre-planned futility analysis. The DMC made this recommendation after evaluating data from the Day 90 follow-up visit of the first 150 patients randomized and treated, as well as the available safety data in the study.
|
· |
Presented Health Economic Data at the Neurocritical Care Society (NCS) 15th Annual Meeting. Edge presented new retrospective, claims-based health economic data showing aSAH per patient hospital charges represent a high economic burden for U.S. hospitals, and ultimately to government and commercial insurers. The analysis also showed that the aSAH patient population currently being studied in the NEWTON 2 study had the highest per patient hospital charges and experienced the longest hospitalizations among all aSAH patients. Specifically, these are patients who require an external ventricular drain (EVD), and undergo either neurosurgical clipping or endovascular coiling for repair of their aneurysm.
|
· |
Received Pediatric Investigation Plan Waiver from the European Medicines Agency. Edge received from the European Medicines Agency a product-specific pediatric waiver for EG-1962 across all subsets of the pediatric population, which removes the requirement for pediatric clinical studies to support a marketing authorization application for EG-1962 in Europe.
|
· |
Secured a Commercial Supply Manufacturer for EG-1962. Edge signed a supply agreement with Oakwood Laboratories for the commercial manufacture of EG-1962 for initial product launch and thereafter.
|
· |
Continued to expand and strengthen the organizational infrastructure and leadership team. Edge appointed experienced executives in regulatory affairs and finance, and added to its Board of Directors.
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Three Months Ended December 31,
|
Twelve Months Ended December 31,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
10,833,679
|
$
|
6,778,806
|
$
|
34,311,650
|
$
|
24,825,379
|
||||||||
General and administrative expenses
|
5,289,461
|
4,159,993
|
17,654,970
|
14,686,767
|
||||||||||||
Total operating expenses
|
16,123,140
|
10,938,799
|
51,966,620
|
39,512,146
|
||||||||||||
Loss from operations
|
(16,123,140
|
)
|
(10,938,799
|
)
|
(51,966,620
|
)
|
(39,512,146
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Other expense
|
-
|
-
|
-
|
(163,463
|
)
|
|||||||||||
Interest income
|
221,606
|
64,027
|
700,903
|
212,299
|
||||||||||||
Interest expense
|
(588,145
|
)
|
(486,411
|
)
|
(2,180,143
|
)
|
(1,203,674
|
)
|
||||||||
Loss before income taxes
|
(16,489,679
|
)
|
(11,361,183
|
)
|
(53,445,860
|
)
|
(40,666,984
|
)
|
||||||||
Benefit for income taxes
|
2,586,057
|
1,845,986
|
2,586,057
|
1,845,986
|
||||||||||||
Net loss and comprehensive loss
|
$
|
(13,903,622
|
)
|
$
|
(9,515,197
|
)
|
$
|
(50,859,803
|
)
|
$
|
(38,820,998
|
)
|
||||
Loss per share basic and diluted
|
$
|
(0.45
|
)
|
$
|
(0.33
|
)
|
$
|
(1.67
|
)
|
$
|
(1.34
|
)
|
||||
Weighted average common shares outstanding basic and diluted
|
30,863,864
|
28,896,941
|
30,393,952
|
28,864,216
|
December 31,
2017
|
December 31,
2016
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
88,067,647
|
$
|
106,398,919
|
||||
Prepaid expenses and other current assets
|
986,680
|
954,581
|
||||||
Total current assets
|
89,054,327
|
107,353,500
|
||||||
Property and equipment, net
|
3,423,880
|
3,418,077
|
||||||
Other assets
|
142,870
|
142,870
|
||||||
Total assets
|
$
|
92,621,077
|
$
|
110,914,447
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
LIABILITIES
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
4,369,133
|
$
|
3,471,032
|
||||
Accrued expenses
|
5,422,205
|
3,213,715
|
||||||
Short term debt
|
3,075,421
|
-
|
||||||
Total current liabilities
|
12,866,759
|
6,684,747
|
||||||
Noncurrent liability:
|
||||||||
Long term debt
|
17,382,907
|
14,953,143
|
||||||
STOCKHOLDERS' EQUITY
|
||||||||
Preferred stock, 5,000,000 shares authorized at December 31, 2017 and 2016, zero outstanding
|
-
|
-
|
||||||
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2017 and December 31, 2016, 30,869,205 shares and 28,918,516 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively
|
10,400
|
9,756
|
||||||
Additional paid-in capital
|
214,309,370
|
190,341,769
|
||||||
Accumulated deficit
|
(151,948,359
|
)
|
(101,074,968
|
)
|
||||
Total stockholders' equity
|
62,371,411
|
89,276,557
|
||||||
Total liabilities and stockholders' equity
|
$
|
92,621,077
|
$
|
110,914,447
|