☒
|
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
26-4231384
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
Non-accelerated filer ☒
|
Smaller Reporting Company ☐
|
Page
|
|||
Part I —
|
Financial Information
|
1
|
|
Item 1.
|
1
|
||
1
|
|||
2
|
|||
3
|
|||
4
|
|||
Item 2.
|
12
|
||
Item 3.
|
20
|
||
Item 4.
|
20
|
||
Part II —
|
Other Information |
21
|
|
Item 1.
|
21
|
||
Item 1A.
|
21
|
||
Item 2.
|
21
|
||
Item 3.
|
21
|
||
Item 4.
|
21
|
||
Item 5.
|
22
|
||
Item 6.
|
22
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
6,507,972
|
$
|
2,418,915
|
$
|
12,574,455
|
$
|
5,636,021
|
||||||||
General and administrative expenses
|
1,976,888
|
1,141,434
|
5,052,983
|
3,540,804
|
||||||||||||
Total operating expenses
|
8,484,860
|
3,560,349
|
17,627,438
|
9,176,825
|
||||||||||||
Loss from operations
|
(8,484,860
|
)
|
(3,560,349
|
)
|
(17,627,438
|
)
|
(9,176,825
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Warrant remeasurement
|
(1,433,502
|
)
|
89,293
|
(1,879,823
|
)
|
183,817
|
||||||||||
Interest income
|
1,333
|
895
|
2,810
|
2,592
|
||||||||||||
Interest expense
|
(213,021
|
)
|
(47,972
|
)
|
(615,047
|
)
|
(47,972
|
)
|
||||||||
Loss before income taxes
|
(10,130,050
|
)
|
(3,518,133
|
)
|
(20,119,498
|
)
|
(9,038,388
|
)
|
||||||||
Benefit for income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
(10,130,050
|
)
|
(3,518,133
|
)
|
(20,119,498
|
)
|
(9,038,388
|
)
|
||||||||
Cumulative dividend on Series C , C-1 and C-2 convertible preferred stock
|
(1,827,568
|
)
|
(364,666
|
)
|
(4,257,083
|
)
|
(1,082,107
|
)
|
||||||||
Net loss attributable to common stockholders
|
$
|
(11,957,618
|
)
|
$
|
(3,882,799
|
)
|
$
|
(24,376,581
|
)
|
$
|
(10,120,495
|
)
|
||||
Loss per share attributable to common stockholders basic and diluted
|
$
|
(7.08
|
)
|
$
|
(2.30
|
)
|
$
|
(14.44
|
)
|
$
|
(5.99
|
)
|
||||
Weighted average common shares outstanding basic and diluted
|
1,688,475
|
1,688,475
|
1,688,475
|
1,688,475
|
Nine Months Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(20,119,498
|
)
|
$
|
(9,038,388
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
1,566,562
|
1,030,215
|
||||||
Warrant remeasurement
|
1,879,823
|
(183,817
|
)
|
|||||
Depreciation expense
|
38,360
|
23,474
|
||||||
Amortization of debt discount
|
79,400
|
8,822
|
||||||
Non-cash interest expense
|
28,667
|
1,596
|
||||||
Changes in assets and liabilities:
|
||||||||
Other receivable
|
-
|
459,018
|
||||||
Prepaid expenses and other assets
|
78,814
|
170,315
|
||||||
Accounts payable
|
(126,415
|
)
|
704,471
|
|||||
Accrued expenses
|
1,604,432
|
(6,361
|
)
|
|||||
Net cash used in operating activities
|
(14,969,855
|
)
|
(6,830,655
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
(799,424
|
)
|
(265,150
|
)
|
||||
Net cash used in investing activities
|
(799,424
|
)
|
(265,150
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of debt
|
3,000,000
|
3,000,000
|
||||||
Payments for deferred issuance costs
|
(474,357
|
)
|
(796,791
|
)
|
||||
Payments for debt issuance costs
|
-
|
(159,136
|
)
|
|||||
Proceeds from issuance of preferred stock, net of issuance costs
|
52,394,571
|
-
|
||||||
Net cash provided by financing activities
|
54,920,214
|
2,044,073
|
||||||
Net increase (decrease) in cash
|
39,150,935
|
(5,051,732
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
13,728,972
|
7,858,169
|
||||||
Cash and cash equivalents at end of period
|
$
|
52,879,907
|
$
|
2,806,437
|
||||
Supplemental disclosure of cash flow information:
|
||||||||
Cash paid for:
|
||||||||
Interest
|
$
|
412,717
|
$
|
-
|
||||
Supplemental cash flow information:
|
||||||||
Deferred issuance costs included in accrued expenses and accounts payable
|
$
|
552,410
|
$
|
768,300
|
||||
Non-cash financing costs
|
$
|
175,114
|
$
|
-
|
||||
Accrued capital expenditures included in accrued expenses
|
$
|
576,839
|
$
|
365,981
|
(A)
|
Unaudited Interim Financial Statements:
|
(B) | Use of estimates: |
(C) | Significant risks and uncertainties: |
(D)
|
Cash equivalents and concentration of cash balance:
|
(E) | Research and development: |
(F) | Stock-based compensation: |
(G) | Net loss per common share: |
As of September 30,
|
||||||||
2015
|
2014
|
|||||||
Stock options to purchase Common Stock
|
4,227,022
|
2,445,690
|
||||||
Convertible preferred stock to purchase Common Stock
|
17,497,815
|
6,093,754
|
||||||
Warrants to purchase Common Stock
|
99,401
|
99,401
|
||||||
Warrants to purchase Series C Preferred Stock
|
338,536
|
338,536
|
||||||
Warrants to purchase Series C-1 Preferred Stock
|
332,484
|
78,596
|
||||||
Total
|
22,495,258
|
9,055,977
|
(H) | Deferred costs: |
(I) | Recently adopted standards: |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Total
|
Quoted Prices in
Active Markets
(Level 1)
|
Quoted Prices in
Inactive Markets
(Level 2)
|
Significant
(Level 3)
|
|||||||||||||
As of September 30, 2015: (unaudited)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
52,879,907
|
$
|
52,879,907
|
$
|
-
|
$
|
-
|
||||||||
Warrant Liability
|
$
|
3,726,043
|
$
|
-
|
$
|
-
|
$
|
3,726,043
|
||||||||
As of December 31, 2014:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
13,728,972
|
$
|
13,728,972
|
$
|
-
|
$
|
-
|
||||||||
Warrant Liability
|
$
|
1,671,106
|
$
|
-
|
$
|
-
|
$
|
1,671,106
|
Warrant
Liability
|
||||
Fair value as of December 31, 2014
|
$ |
1,671,106
|
||
Fair value of warrants issued
|
175,114
|
|||
Change in fair value
|
1,879,823
|
|||
Fair value as of September 30, 2015
|
$
|
3,726,043
|
September 30,
|
December 31, | |||||||
2015
|
2014
|
|||||||
(unaudited)
|
||||||||
Accrued research and development costs
|
$
|
1,819,629
|
$
|
471,267
|
||||
Accrued professional fees
|
420,891
|
318,649
|
||||||
Accrued compensation
|
819,714
|
600,000
|
||||||
Accrued other
|
493,399
|
149,738
|
||||||
Deferred rent
|
36,589
|
42,508
|
||||||
Total
|
$
|
3,590,222
|
$
|
1,582,162
|
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Stock Based Compensation
|
||||||||||||||||
Research and development
|
$
|
273,782
|
$
|
142,753
|
$
|
702,322
|
$
|
457,377
|
||||||||
General and administrative
|
338,096
|
137,237
|
864,240
|
572,838
|
||||||||||||
Total
|
$
|
611,878
|
$
|
279,990
|
$
|
1,566,562
|
$
|
1,030,215
|
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Weighted
Average
|
Weighted
Average
|
Weighted
Average
|
Weighted
Average
|
|||||||||||||
Volatility
|
79.80
|
%
|
75.00
|
%
|
79.80
|
%
|
75.54
|
%
|
||||||||
Risk-Free Interest Rate
|
1.59
|
%
|
1.88
|
%
|
1.74
|
%
|
1.96
|
%
|
||||||||
Expected Term in Years
|
6.08
|
5.95
|
6.08
|
5.78
|
||||||||||||
Dividend Rate
|
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
||||||||
Fair Value of Option on Grant Date
|
$
|
7.51
|
$
|
4.68
|
$
|
5.22
|
$
|
5.35
|
Number of
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at December 31, 2014
|
2,445,713
|
$
|
3.13
|
|||||||||||||
Granted
|
1,822,609
|
|
7.56
|
|||||||||||||
Exercised
|
-
|
-
|
||||||||||||||
Forfeited
|
(30,640
|
)
|
7.98
|
|||||||||||||
Expirations
|
(10,660
|
)
|
8.28
|
|||||||||||||
Options outstanding at September 30, 2015
|
4,227,022
|
$
|
5.00
|
8.36
|
$
|
25,377,366
|
||||||||||
Vested and expected to vest at September 30, 2015
|
4,121,868
|
$
|
4.94
|
8.33
|
$
|
24,969,093
|
||||||||||
Exercisable at September 30, 2015
|
1,799,999
|
$
|
2.94
|
7.32
|
$
|
14,501,041
|
Issue Date
|
Series
|
Number of Shares
|
Price per
Share
|
Proceeds
(in thousands)
|
Common Stock
Conversion Price
|
Common shares
on conversion
|
Offer Costs
(in thousands)
|
|||||||||||||||||||||
2009
|
A |
390,486
|
$
|
1.00
|
$
|
390
|
$
|
1.37
|
285,422
|
$
|
25
|
|||||||||||||||||
2010
|
A |
|
474,014
|
$
|
1.00
|
$
|
474
|
$
|
1.37
|
346,476
|
$
|
43
|
||||||||||||||||
2011
|
B
|
2,333,000
|
$
|
1.25
|
$
|
2,916
|
$
|
1.71
|
1,705,284
|
$
|
27
|
|||||||||||||||||
2011
(1)
|
B
|
|
82,116
|
$
|
1.25
|
$
|
103
|
$
|
1.71
|
60,021
|
---
|
|||||||||||||||||
2012
|
B-1
|
359,935
|
$
|
1.75
|
$
|
630
|
$
|
2.39
|
263,091
|
$
|
153
|
|||||||||||||||||
2013
|
C
|
4,631,505
|
$
|
3.85
|
$
|
17,831
|
$
|
5.27
|
3,385,355
|
$
|
2,747
|
|||||||||||||||||
2013
(2)
|
C |
|
65,809
|
$
|
3.85
|
$
|
253
|
$
|
5.27
|
48,102
|
---
|
|||||||||||||||||
2014
|
C-1
|
3,558,890
|
$
|
4.65
|
$
|
16,549
|
$
|
6.36
|
2,601,337
|
$
|
2,022
|
|||||||||||||||||
2015
|
C-2
|
12,043,006
|
$
|
4.65
|
$
|
56,000
|
$
|
6.36
|
8,802,723
|
$
|
3,783
|
(1) | Conversion of $100,000 NJEDA Note plus accrued interest of $2,645. |
(2) | Conversion of $250,000 promissory note plus accrued interest of $3,365. |
Year ended December 31,
|
||||
2015 (remaining)
|
$
|
57,238
|
||
2016
|
232,350
|
|||
2017
|
232,221
|
|||
2018
|
236,307
|
|||
2019 and after
|
39,498
|
|||
Total minimum payments required
|
$
|
797,614
|
Year Ending in December 31:
|
(000's)
|
|||
2015 remaining
|
$
|
534
|
||
2016
|
2,271
|
|||
2017
|
2,513
|
|||
2018
|
682
|
|||
$
|
6,000
|
• | the accuracy of our estimates regarding expenses, future revenues and capital requirements; |
• | our plans to develop and commercialize our product candidates; |
• | our ability to complete our ongoing clinical trials and to advance our product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials; |
• | regulatory developments in the United States and foreign countries; |
• | the performance of our third-party manufacturers and contract research organizations; |
• | our ability to obtain and maintain intellectual property protection for our proprietary assets; |
• | the size of the potential markets for our product candidates and our ability to serve those markets; |
• | the rate and degree of market acceptance of our product candidates for any indication once approved; |
• | our ability to obtain additional financing; |
• | the success of competing products that are or become available for the indications that we are pursuing; |
• | the loss of key scientific or management personnel; |
• | our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) |
• | our use of the net proceeds from the IPO; and |
• | other risks and uncertainties, including those listed under Part II, Item 1A. Risk Factors. |
• | conduct clinical trials of our initial product candidates, including the commencement of our Phase 3 program for EG-1962; |
• | continue our research and development efforts; |
• | conduct preclinical studies and initiate clinical trials for EG-1964 for the treatment of cSDH; |
• | manufacture preclinical study and clinical trial materials and scale-up for commercial manufacturing capabilities; |
• | hire additional clinical, quality control, technical and scientific personnel to conduct our clinical trials and to support our product development efforts; |
• | seek regulatory approvals for our product candidates that successfully complete clinical trials; |
• | maintain, expand and protect our intellectual property portfolio; |
• | implement operational, financial and management systems; and |
• | hire additional general and administrative personnel to support our operation as a public company. |
Three Months Ended September 30,
|
Increase (Decrease)
|
|||||||||||||||
2015
|
2014
|
$
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
6,508
|
$
|
2,419
|
$
|
4,089
|
169
|
%
|
||||||||
General and administrative expenses
|
1,977
|
1,141
|
836
|
73
|
%
|
|||||||||||
Total operating expenses
|
8,485
|
3,560
|
4,925
|
138
|
%
|
|||||||||||
Loss from operations
|
(8,485
|
)
|
(3,560
|
)
|
(4,925
|
)
|
138
|
%
|
||||||||
Warrant remeasurement
|
(1,434
|
)
|
89
|
(1,523
|
)
|
1711
|
%
|
|||||||||
Interest income (expense), net
|
(212
|
)
|
(47
|
)
|
(165
|
)
|
NM
|
|||||||||
Loss before income taxes
|
(10,131
|
)
|
(3,518
|
)
|
(6,613
|
)
|
188
|
%
|
||||||||
Benefit for income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
$
|
(10,131
|
)
|
$
|
(3,518
|
)
|
$
|
(6,613
|
)
|
188
|
%
|
Nine Months Ended September 30,
|
Increase (Decrease)
|
|||||||||||||||
2015
|
2014
|
$
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
12,574
|
$
|
5,636
|
$
|
6,938
|
123
|
%
|
||||||||
General and administrative expenses
|
5,053
|
3,541
|
1,512
|
43
|
%
|
|||||||||||
Total operating expenses
|
17,627
|
9,177
|
8,450
|
92
|
%
|
|||||||||||
Loss from operations
|
(17,627
|
)
|
(9,177
|
)
|
(8,450
|
)
|
92
|
%
|
||||||||
Warrant remeasurement
|
(1,880
|
)
|
184
|
(2,064
|
)
|
1122
|
%
|
|||||||||
Interest income (expense), net
|
(612
|
)
|
(45
|
)
|
(567
|
)
|
NM
|
|||||||||
Loss before income taxes
|
(20,119
|
)
|
(9,038
|
)
|
(11,081
|
)
|
123
|
%
|
||||||||
Benefit for income taxes
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
$
|
(20,119
|
)
|
$
|
(9,038
|
)
|
$
|
(11,081
|
)
|
123
|
%
|
Nine Months Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Net cash used in operating activities
|
$
|
(14,970
|
)
|
$
|
(6,831
|
)
|
||
Net cash used in investing activities
|
(799
|
)
|
(265
|
)
|
||||
Net cash provided by financing activities
|
54,920
|
2,044
|
||||||
Net increase (decrease) in cash
|
$
|
39,151
|
$
|
(5,052
|
)
|
• | the initiation, progress, timing, costs and results of the clinical trials for our product candidates to meet regulatory approval, particularly whether the FDA requires us to complete two Phase 3 trials for EG-1962 or changes to the anticipated design of our Phase 3 program, such as changes in the required control arm of any such trial; |
• | the outcome of planned 2015 interactions with the FDA and other non-U.S. health authorities that may alter our proposed Phase 3 program for EG-1962 that is required to meet the standards of a marketing authorization approval in aSAH; |
• | the clinical development plans we establish for these product candidates; |
• | the number and characteristics of product candidates that we develop or may in-license; |
• | the outcome, timing and cost of meeting regulatory requirements established by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect; |
• | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights; |
• | the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates; |
• | the effect of competing technological and market developments; |
• | the cost and timing of completion of commercial-scale outsourced manufacturing activities; and |
• | the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own. |
As of September 30, 2015
|
Total
|
Less than
one year
|
1-3 Years
|
3-5 Years
|
More than
5 Years
|
|||||||||||||||
(in thousands)
|
||||||||||||||||||||
Debt principal and interest
|
$
|
6,816
|
$
|
2,721
|
$
|
4,095
|
$
|
-
|
$
|
-
|
||||||||||
Operating lease obligations
|
|
797
|
|
231
|
|
566
|
|
-
|
|
-
|
||||||||||
Total contractual obligations
|
$
|
7,613
|
$
|
2,952
|
$
|
4,661
|
$
|
-
|
$
|
-
|
Edge Therapeutics, Inc.
|
|
November 6, 2015
|
By:
/s/ Brian A. Leuthner
|
Brian A. Leuthner
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
November 6, 2015
|
By:
/s/ Andrew J. Einhorn
|
Andrew J. Einhorn
|
|
Chief Financial Officer
|
|
(Principal Financial Officer)
|
Exhibit
Number
|
Exhibit Description
|
|
3.1
|
Eight Amended and Restated Certificate of Incorporation of Edge Therapeutics, Inc.
(
filed as exhibit 3.1 to the
Company’s
Current Report on Form 8-K filed on October 6, 2015, and incorporated by reference herein
)
|
|
3.2
|
Second Amended and Restated Bylaws of Edge Therapeutics, Inc.
(
filed as exhibit 3.2 to the
Company’s
Current Report on Form 8-K filed on October 6, 2015, and incorporated by reference herein
)
|
|
Warrant to Purchase 18,000 Shares of Common Stock issued to Maxim Partners LLC, dated as of October 6, 2015.
|
||
10.1
|
+
|
Amended and Restated Employment Agreement by and between Herbert J. Faleck and the Company dated as of August 11, 2015 (filed as exhibit 10.13 to the Company’s registration statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
)
.
|
10.2
|
+
|
Second Amended and Restated Employment Agreement by and between Dr. R. Loch Macdonald and the Company dated September 21, 2015 (filed as exhibit 10.14 to the Company’s Pre-Effective Amendment No. 1 to the registration statement on Form S-1 (File No. 333- 206416) filed on September 21, 2015, and incorporated by reference herein
)
.
|
10.3
|
*
|
Amendment No. 1 to the License Agreement, effective as of September 21, 2015, by and between the Company and Evonik Corporation. (filed as exhibit 10.15 to the Company’s Pre-Effective Amendment No. 1 to the registration statement on Form S-1 (File No. 333- 206416) filed on September 21, 2015, and incorporated by reference herein
)
.
|
Principal Executive Officer’s Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
Principal Financial Officer’s Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
||
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
(1) | This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. |
+
|
Indicates management contract or compensatory plan. |
*
|
Confidential Treatment has been granted with respect to certain portions of this Exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission. |
Warrant No. W-6
|
Shares of Common Stock: 18,000
|
EDGE THERAPEUTICS, INC.
|
|||
By:
|
/s/ Brian A. Leuthner
|
||
Name: Brian A. Leuthner
|
|||
Title: President & Chief Executive Officer
|
|
|
|
|
|
|
|
☐ |
by
cash in accordance with Section 1(a) of the Warrant
|
☐ |
via
cashless exercise in accordance with Section 1(c) of the Warrant in the following manner:
|
Dated:
|
|
||
Print or Type Name
|
||
|
||
(Signature must conform in all respects to name of holder as specified on the face of Warrant)
|
||
|
||
(Street Address)
|
||
|
||
(City) (State) (Zip Code)
|
Dated:
|
||
(Signature must conform in all respects
|
||
to name of holder as specified on the
|
||
face of Warrant)
|
||
|
||
(Street Address)
|
||
|
||
(City) (State) (Zip Code)
|
|
||
(Signature of Transferee)
|
||
|
||
(Street Address)
|
||
|
||
(City) (State) (Zip Code)
|
1. | I have reviewed this Quarterly Report on Form 10-Q of Edge Therapeutics, Inc. for the period ended September 30, 2015; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
c) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Dated: November 6, 2015
|
/s/ Brian A. Leuthner
|
Brian A. Leuthner
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Edge Therapeutics, Inc. for the period ended September 30, 2015;
|
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
c) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Dated: November 6, 2015
|
/s/ Andrew J. Einhorn
|
Andrew J. Einhorn
|
|
Chief Financial Officer
|
|
(Principal Financial Officer)
|
(1) | the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: November 6, 2015
|
/s/ Brian A. Leuthner
|
Brian A. Leuthner
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
(1) | the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: November 6, 2015
|
/s/ Andrew J. Einhorn
|
Andrew J. Einhorn,
|
|
Chief Financial Officer
|
|
(Principal Financial Officer)
|