Edge Therapeutics, Inc.
|
(Exact name of registrant as specified in its charter)
|
Delaware
|
26-4231384
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
300 Connell Drive, Suite 4000, Berkeley Heights, NJ 07922
|
(Address of principal executive offices)
|
(800) 208-3343
|
(Registrant’s telephone number)
|
Large accelerated filer
☐
|
Accelerated filer
☐
|
Non-accelerated filer
☐
|
Smaller Reporting Company
☒
|
Emerging growth company
☒
|
PAGE
|
||
PART I
|
||
Item 1
|
4
|
|
Item 1A
|
8
|
|
Item 1B
|
28
|
|
Item 2
|
28
|
|
Item 3
|
28
|
|
Item 4
|
28
|
|
PART II
|
||
Item 5
|
29
|
|
Item 6
|
Selected Financial Data
|
29 |
Item 7
|
30
|
|
Item 8
|
38
|
|
Item 9
|
38
|
|
Item 9A
|
38
|
|
Item 9B
|
38
|
|
PART III
|
||
Item 10
|
39
|
|
Item 11
|
45
|
|
Item 12
|
51
|
|
Item 13
|
52
|
|
Item 14
|
53
|
|
PART IV
|
||
Item 15
|
55
|
|
Item 16
|
55
|
|
59
|
● |
the expected benefits of and potential value created by the proposed merger among Edge Therapeutics, Inc., a Delaware corporation, or Edge, Echos Merger Sub, Inc., a
Delaware corporation and a wholly-owned subsidiary of Edge, or Merger Sub, and PDS Biotechnology Corporation, a Delaware corporation, or PDS, for the stockholders of Edge;
|
● |
the likelihood of the satisfaction of certain conditions to the completion of the merger and whether and when the merger will be consummated;
|
● |
Edge’s ability to control and correctly estimate its operating expenses and its expenses associated with the merger;
|
● |
the plans, strategies and objectives of management for future operations, including the execution of integration plans and the anticipated timing of filings;
|
● |
the plans to develop and commercialize additional products;
|
● |
the attraction and retention of highly qualified personnel;
|
● |
the ability to protect and enhance the combined company’s products and intellectual property;
|
● |
developments and projections relating to the combined company’s competitors or industry;
|
● |
the combined company’s financial performance;
|
● |
expectations concerning Edge’s or PDS’s relationships and actions with third parties;
|
● |
future regulatory, judicial and legislative changes in Edge’s or PDS’s industry; and
|
● |
other risks and uncertainties, including those listed under Item 1A. Risk Factors.
|
● |
Pursue another strategic transaction similar to the merger. Edge may resume its process of evaluating other companies interested in pursuing a strategic transaction with
Edge and, if a candidate is identified, focus its attention on negotiating and completing such a transaction with such candidate.
|
● |
Dissolve and liquidate its assets. If Edge is unable, or does not believe that it is able, to find a suitable candidate for another strategic transaction, Edge may dissolve
and liquidate its assets. In the event of dissolution, Edge would be required to pay all of its debts and contractual obligations and to set aside certain reserves for potential future claims. If Edge dissolves and liquidates its
assets, there can be no assurance as to the amount or timing of available cash that will remain for distribution to Edge’s stockholders after paying Edge’ debts and other obligations and setting aside funds for its reserves.
|
● |
completion of preclinical laboratory tests, animal trials and formulation trials conducted according to Good Laboratory Practices, animal welfare laws and other applicable
regulations;
|
● |
submission to the FDA of an Investigational New Drug, or IND, application which must become effective before clinical trials (trials in human subjects) in the United States
may begin, obtaining similar authorizations in other jurisdictions where clinical research will be conducted and maintaining these authorizations on a continuing basis throughout the time that trials are performed and new data are
collected;
|
● |
performance of adequate and well-controlled clinical trials according to Good Clinical Practices to demonstrate whether a proposed drug is safe and effective for its
proposed intended use;
|
● |
preparation and submission to the FDA of a marketing authorization application, such as a new drug application, or NDA, and submitting similar marketing authorization
applications in other jurisdictions where commercialization will be pursued;
|
● |
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product will be produced to assess compliance with cGMP to assure that
the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; and
|
● |
FDA review and approval of the NDA or other marketing authorization application.
|
● |
if the Merger Agreement is terminated under certain circumstances and certain events occur, Edge will be required to pay PDS a termination fee of $1.75 million;
|
● |
the price of Edge stock may decline and remain volatile; and
|
● |
costs related to the merger, such as legal, accounting and investment banking fees which Edge and PDS estimate will total approximately $
5.3
million, of which $
3.5
million must be paid even if the merger is not completed.
|
● |
any effect, change, event, circumstance or development in general economic or business conditions generally affecting the industries in which PDS or Edge operate;
|
● |
any act of war, armed hostilities or terrorism;
|
● |
any changes in financial, banking or securities markets;
|
● |
the taking of any action required to be taken by the Merger Agreement;
|
● |
any changes in accounting requirements or principles or any change in applicable laws, rules or regulations or the interpretation thereof;
|
● |
any effect resulting from the announcement or pendency of the merger or any related transactions;
|
● |
with respect to Edge, any change in the stock price or trading volume of Edge common stock; or
|
● |
with respect to Edge, any clinical trial programs or studies, including any adverse data, event or outcome arising out of or related to any such programs or studies.
|
● |
investors react negatively to the prospects of the combined company’s business and prospects from the merger;
|
● |
the effect of the merger on the combined company’s business and prospects is not consistent with the expectations of financial or industry analysts; or
|
● |
the combined company does not achieve the perceived benefits of the merger as rapidly or to the extent anticipated by financial or industry analysts.
|
● |
the attention of Edge’s management may be directed toward the closing of the merger and related matters and may be diverted from the day-to-day business operations; and
|
● |
third parties may seek to terminate or renegotiate their relationships with Edge as a result of the merger, whether pursuant to the terms of their existing agreements with
Edge or otherwise.
|
● |
Edge has incurred and expects to continue to incur significant expenses related to the proposed merger even if the merger is not consummated;
|
● |
Edge could be obligated to pay PDS a termination fee of up to $1.75 million under certain circumstances pursuant to the Merger Agreement;
|
● |
the market price of Edge common stock may decline to the extent that the current market price reflects a market assumption that the proposed merger will be completed; and
|
● |
Edge may not be able to pursue an alternate merger transaction if the proposed merger with PDS is not completed.
|
● |
providing adequate and well-controlled data that the product candidate is safe and effective and shows a significant benefit over the active comparator in patients for the
intended indication;
|
● |
demonstrating that the product candidate formulation is reproducible and can meet the relevant release specifications for each market Edge intends to commercialize in; and
|
● |
completing the development and scale-up to permit manufacture of Edge’s product candidates in commercial quantities and at acceptable prices.
|
● |
disagreement with, or disapproval of, the design of, procedures for, or implementation of, clinical trials;
|
● |
the inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial;
|
● |
disagreement with the sufficiency of the final content and data included in a marketing application;
|
● |
feedback from the FDA or a comparable foreign regulatory authority on results from earlier stage or concurrent preclinical and clinical studies, that might require
modification to the protocol;
|
● |
a decision by the FDA or a comparable foreign regulatory authority to suspend or terminate clinical trials at any time for safety issues or for any other reason;
|
● |
challenges in meeting regulatory requirements to commence clinical trials in countries outside the United States;
|
● |
failure to conduct the trial in accordance with regulatory requirements;
|
● |
failure to demonstrate that the product candidate provides an overall benefit to risk or significant enough improvement over the comparator in the proposed indication;
|
● |
failure of the product candidate to demonstrate efficacy at the level of statistical significance required for approval;
|
● |
a negative interpretation of the data from preclinical studies or clinical trials;
|
● |
deficiencies in the manufacturing processes or failure of third party manufacturing facilities to effectively and consistently manufacture product or to pass FDA
pre-approval facility inspection;
|
● |
failure to demonstrate adequate and reproducible product stability to support product commercialization;
|
● |
failure to adequately demonstrate process performance qualification prior to product commercialization;
|
● |
inability to validate analytical and microbiological methods consistent with industry and government agency expectations; or
|
● |
changes in governmental regulations or administrative actions.
|
● |
regulatory actions with respect to Edge;
|
● |
the recruitment or departure of key personnel;
|
● |
announcements by Edge or Edge’s competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
|
● |
regulatory or legal developments in the United States and other countries;
|
● |
developments or disputes concerning patent applications, issued/granted patents or other proprietary rights;
|
● |
the level of Edge’s expenses;
|
● |
actual or anticipated changes in estimates as to financial results;
|
● |
variations in Edge’s financial results or those of companies that are perceived to be similar to Edge;
|
● |
fluctuations in the valuation of companies perceived by investors to be comparable to Edge;
|
● |
share price and volume fluctuations attributable to inconsistent trading volume levels of Edge’s shares;
|
● |
announcement or expectation of additional financing efforts;
|
● |
sales of Edge’s common stock by Edge, Edge’s insiders or Edge’s other stockholders;
|
|
● |
market conditions in the pharmaceutical and biotechnology sectors; and
|
|
● |
general economic, industry and market conditions.
|
● |
authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
|
● |
prohibiting cumulative voting in the election of directors, which would otherwise allow for less than a majority of stockholders to elect director candidates;
|
● |
prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of Edge’s stockholders;
|
● |
eliminating the ability of stockholders to call a special meeting of stockholders;
|
● |
establishing a staggered board of directors; and
|
● |
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.
|
● |
the ability of the combined company or its partners to develop product candidates and conduct clinical trials that demonstrate such product candidates are safe and
effective;
|
● |
the ability of the combined company or its partners to obtain regulatory approvals for product candidates, and delays or failures to obtain such approvals;
|
● |
failure of any of the combined company’s product candidates to demonstrate safety and efficacy, receive regulatory approval and achieve commercial success;
|
● |
failure by the combined company to maintain its existing third-party license, manufacturing and supply agreements;
|
● |
failure by the combined company or its licensors to prosecute, maintain, or enforce its intellectual property rights;
|
● |
changes in laws or regulations applicable to the combined company’s product candidates;
|
● |
any inability to obtain adequate supply of product candidates or the inability to do so at acceptable prices;
|
● |
adverse regulatory authority decisions;
|
● |
introduction of new or competing products by its competitors;
|
● |
failure to meet or exceed financial and development projections the combined company may provide to the public;
|
● |
the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
|
● |
announcements of significant acquisitions, strategic partnerships, joint ventures, or capital commitments by the combined company or its competitors;
|
● |
disputes or other developments relating to proprietary rights, including patents, litigation matters, and the combined company’s ability to obtain intellectual property
protection for its technologies;
|
● |
additions or departures of key personnel;
|
● |
significant lawsuits, including intellectual property or stockholder litigation;
|
● |
if securities or industry analysts do not publish research or reports about the combined company, or if they issue an adverse or misleading opinions regarding its business
and stock;
|
● |
changes in the market valuations of similar companies;
|
● |
general market or macroeconomic conditions;
|
● |
sales of its common stock by the combined company or its stockholders in the future;
|
● |
trading volume of the combined company’s common stock;
|
● |
adverse publicity relating to the combined company’s markets generally, including with respect to other products and potential products in such markets;
|
● |
changes in the structure of health care payment systems; and
|
● |
period-to-period fluctuations in the combined company’s financial results.
|
Year Ended December 31, 2018
|
High
|
Low
|
||||||
Fourth Quarter
|
$
|
1.09
|
$
|
0.31
|
||||
Third Quarter
|
$
|
1.10
|
$
|
0.70
|
||||
Second Quarter
|
$
|
1.28
|
$
|
0.87
|
||||
First Quarter
|
$
|
17.47
|
$
|
1.18
|
||||
Year Ended December 31, 2017
|
High
|
Low
|
||||||
Fourth Quarter
|
$
|
11.16
|
$
|
9.07
|
||||
Third Quarter
|
$
|
11.51
|
$
|
9.20
|
||||
Second Quarter
|
$
|
10.72
|
$
|
8.81
|
||||
First Quarter
|
$
|
12.99
|
$
|
7.62
|
|
(A)
|
(B)
|
(C)
|
|||||||||
Plan category
|
Number of
securities
to be issued
upon exercise
of outstanding
options, warrants
and rights
|
Weighted-
average
exercise price
of outstanding
options, warrants
and rights
($)
|
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in column (A))
|
|||||||||
Equity compensation plans approved by security holders
|
7,238,787
|
5.41
|
136,228
|
|||||||||
Equity compensation plans not approved by security holders
|
315,003
|
8.35
|
-
|
|||||||||
Total
|
7,553,787
|
5.68
|
136,228
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
EG-1962 product candidate
|
$
|
9,504
|
$
|
22,075
|
||||
EG-1964 product candidate
|
5
|
640
|
||||||
Pipeline
|
188
|
371
|
||||||
Internal Operating Expenses
|
6,372
|
11,226
|
||||||
Total
|
$
|
16,069
|
$
|
34,312
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
General and administrative expenses
|
$
|
14,291
|
$
|
17,655
|
|
Year Ended December 31,
|
|||||||
2018
|
2017
|
|||||||
Weighted Average
|
Weighted Average
|
|||||||
Volatility
|
86.33
|
%
|
88.87
|
%
|
||||
Risk-Free Interest Rate
|
2.23
|
%
|
1.88
|
%
|
||||
Expected Term in Years
|
6.00
|
6.00
|
||||||
Dividend Rate
|
0.00
|
%
|
0.00
|
%
|
||||
Fair Value of Option on Grant Date
|
$
|
5.08
|
$
|
6.93
|
Year Ended December 31,
|
Increase (Decrease)
|
|||||||||||||||
2018
|
2017
|
$
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
16,069
|
$
|
34,312
|
$
|
(18,243
|
)
|
(53
|
)%
|
|||||||
General and administrative expenses
|
14,291
|
17,655
|
(3,364
|
)
|
(19
|
)%
|
||||||||||
Restructuring expenses
|
9,914
|
–
|
9,914
|
100
|
%
|
|||||||||||
Impairment charges
|
2,823
|
–
|
2,823
|
100
|
%
|
|||||||||||
Total operating expenses
|
43,097
|
51,967
|
(8,870
|
)
|
(17
|
)%
|
||||||||||
Loss from operations
|
(43,097
|
)
|
(51,967
|
)
|
8,870
|
(17
|
)%
|
|||||||||
Interest income (expense), net
|
(553
|
)
|
(1,479
|
)
|
926
|
(63
|
)%
|
|||||||||
Loss before income taxes
|
(43,650
|
)
|
(53,446
|
)
|
9,796
|
(18
|
)%
|
|||||||||
Benefit for income taxes
|
2,782
|
2,586
|
196
|
8
|
%
|
|||||||||||
Net loss and comprehensive loss
|
$
|
(40,868
|
)
|
$
|
(50,860
|
)
|
$
|
9,992
|
(20
|
)%
|
● |
Pursue another strategic transaction similar to the merger. Edge may resume its process of evaluating other companies interested in pursuing a strategic transaction with
Edge and, if a candidate is identified, focus its attention on negotiating and completing such a transaction with such candidate.
|
● |
Dissolve and liquidate its assets. If Edge is unable, or does not believe that it is able, to find a suitable candidate for another strategic transaction, Edge may dissolve
and liquidate its assets. In the event of dissolution, Edge would be required to pay all of its debts and contractual obligations and to set aside certain reserves for potential future claims. If Edge dissolves and liquidates its
assets, there can be no assurance as to the amount or timing of available cash that will remain for distribution to Edge’ stockholders after paying Edge’ debts and other obligations and setting aside funds for its reserves.
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Net cash used in operating activities
|
$
|
(33,153
|
)
|
$
|
(40,697
|
)
|
||
Net cash used in investing activities
|
–
|
(188
|
)
|
|||||
Net cash (used in) provided by financing activities
|
(20,269
|
)
|
22,554
|
|||||
Net decrease in cash
|
$
|
(53,422
|
)
|
$
|
(18,331
|
)
|
● |
our ability to timely consummate the merger with PDS;
|
● |
the costs incurred in defending the class action civil litigation;
|
● |
the costs incurred in responding to disruptive actions by activist stockholders;
|
● |
the timing and nature of any strategic transactions that we undertake;
|
● |
personnel-related expenses, including salaries, benefits, severance, stock-based compensation expense and other compensation costs related to implementing our restructuring
plan;
|
● |
the scope and nature of activities we may pursue to advance clinical development for our product candidates, if any; and
|
● |
the number and characteristics of product candidates that we develop or may acquire or in-license;
|
As of December 31, 2018
|
Total
|
Less than One Year
|
1-3 Years
|
3-5 Years
|
More than 5 Years
|
|||||||||||||||
(in thousands)
|
||||||||||||||||||||
Operating lease obligations
|
$
|
1,739
|
$
|
605
|
$
|
1,134
|
$
|
–
|
$
|
–
|
||||||||||
Total contractual obligations
|
$
|
1,739
|
$
|
605
|
$
|
1,134
|
$
|
–
|
$
|
–
|
Name
|
Age
|
Director Since
|
||
(Class A − Term expiring at annual meeting of stockholders in 2019)
|
||||
Rose Crane
|
59
|
2017
|
||
Liam Ratcliffe, M.D., Ph.D.
|
55
|
2016
|
||
Robert Spiegel, M.D.
|
69
|
2013
|
||
(Class B − Term expiring at annual meeting of stockholders in 2020)
|
||||
Isaac Blech
|
69
|
2013
|
||
James Loughlin
|
75
|
2011
|
||
R. Loch Macdonald, M.D., Ph.D.
|
57
|
2009
|
||
(Class C − Term expiring at annual meeting of stockholders in 2021)
|
||||
Sol Barer, Ph.D.
|
71
|
2011
|
||
Brian A. Leuthner |
54
|
2009 |
Name
|
Age
|
Position
|
||
Brian A. Leuthner
|
54
|
President, Chief Executive Officer and Director
|
||
Andrew Saik
|
49
|
Chief Financial Officer
|
||
W. Bradford Middlekauff
|
57
|
Senior Vice President, General Counsel and Secretary
|
Name
|
Audit
|
Compensation
|
Nominating
and Corporate
Governance
|
|||
Sol Barer, Ph.D.
|
X
|
X*
|
||||
Isaac Blech
|
X
|
|||||
Rose Crane
|
X
|
|||||
James Loughlin
|
X*
|
|||||
Liam Ratcliffe, M.D., Ph.D.
|
X
|
|||||
Robert Spiegel, M.D.
|
X
|
X*
|
X
|
* |
Committee Chairperson
|
● |
hiring an independent registered public accounting firm to conduct the annual audit of our financial statements and monitoring its independence and performance;
|
● |
reviewing and approving the planned scope of the annual audit and the results of the annual audit;
|
● |
pre-approving all audit services and permissible non-audit services provided by our independent registered public accounting firm;
|
● |
reviewing the significant accounting and reporting principles to understand their impact on our financial statements;
|
● |
reviewing our internal financial, operating and accounting controls with management and our independent registered public accounting firm;
|
● |
reviewing with management and our independent registered public accounting firm, as appropriate, our financial reports, earnings announcements and our compliance with
legal and regulatory requirements;
|
● |
reviewing potential conflicts of interest under and violations of our Code of Conduct;
|
● |
establishing procedures for the treatment of complaints received by us regarding accounting, internal accounting controls or auditing matters and confidential submissions
by our employees of concerns regarding questionable accounting or auditing matters;
|
● |
reviewing and approving related-party transactions;
|
● |
primary responsibility for overseeing our risk management function; and
|
● |
reviewing and evaluating, at least annually, our Audit Committee’s charter.
|
● |
designing and implementing competitive compensation policies to attract and retain key personnel;
|
● |
reviewing and formulating policy and determining the compensation of our executive officers and employees;
|
● |
reviewing and recommending to the Edge Board the compensation of our directors;
|
● |
administering our equity incentive plans and granting equity awards to our employees and directors under these plans;
|
● |
if required from time to time, reviewing with management our disclosures under the caption “Compensation Discussion and Analysis” and recommending to the full board its
inclusion in our periodic reports to be filed with the SEC;
|
● |
if required from time to time, preparing the report of the Compensation Committee to be included in our annual proxy statement;
|
● |
engaging compensation consultants or other advisors it deems appropriate to assist with its duties; and
|
● |
reviewing and evaluating, at least annually, our Compensation Committee’s charter.
|
● |
identifying, reviewing and evaluating candidates to serve on the Edge Board;
|
● |
determining the minimum qualifications for service on the Edge Board;
|
● |
developing and recommending to the Edge Board an annual self-evaluation process for the Edge Board and overseeing the annual self-evaluation process;
|
● |
developing, as appropriate, a set of corporate governance principles, and reviewing and recommending to the Edge Board any changes to such principles; and
|
● |
periodically reviewing and evaluating our Nominating and Corporate Governance Committee’s charter.
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Option
Awards
(1)
($)
|
Restricted
Stock Units
($)
|
All Other
Compensation
(2)
($)
|
Total
($)
|
|||||||||||||||||||||
Brian A. Leuthner
Chief Executive Officer
|
2018
2017
|
530,000
500,000
|
318,000
255,000
|
3,356,300
1,761,831
|
143,846
-
|
10,800
10,800
|
4,358,946
2,527,631
|
|||||||||||||||||||||
R. Loch Macdonald, M.D., Ph.D.
Chief Scientific Officer
(3)
|
2018
2017
|
150,750
402,000
|
-
153,765
|
11,578
724,493
|
8,510
-
|
272,179
10,800
|
443,017
1,291,059
|
|||||||||||||||||||||
Herbert J. Faleck
Chief Medical Officer
(4)
|
2018
2017
|
416,000
400,000
|
187,200
724,493
|
646,945
153,000
|
50,918
-
|
10,800
10,800
|
1,311,863
1,288,293
|
|||||||||||||||||||||
Andrew Saik
|
2018
|
370,000
|
166,500
|
660,490
|
70,632
|
-
|
1,267,622
|
|||||||||||||||||||||
Chief Financial Officer
|
2017
|
61,667
|
-
|
1,594,402
|
-
|
-
|
1,656,069
|
|||||||||||||||||||||
W. Bradford Middlekauff
|
2018
|
347,700
|
156,470
|
791,426
|
42,351
|
10,800
|
1,348,747
|
|||||||||||||||||||||
SVP, General Counsel and Secretary
|
2017
|
328,000
|
97,580
|
345,782
|
-
|
10,800
|
782,162
|
(1) |
Amounts shown in this column do not reflect actual compensation received by the named executive officers. The amounts reflect the grant date fair value of stock option
awards and are calculated in accordance with the provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718- Stock Compensation, and assume no forfeiture rate derived in the calculation of the grant
date fair value of these awards. Assumptions used in calculating the value of these awards are included in Note 7, “Stock Options” in the notes to Edge’s financial statements included in this Annual Report. The executive will only
realize compensation to the extent the trading price of Edge’s common stock is greater than the exercise price of such stock options at the time such options are exercised.
|
(2) |
Amounts shown in this column reflect Edge’s matching contributions to Edge’s 401(k) plan in the amount of $10,800 except that, due to Dr. Macdonald’s termination on May 15,
2018, Edge’s contributions to the 401(k) plan for Dr. Macdonald in 2018 were $6,110. For Dr. Macdonald, the amount shown in this column also includes the dollar value of severance benefits paid through December 31, 2018, which is
comprised of continuation of Dr. Macdonald’s base salary ($251,250) and reimbursements of amounts paid for health care continuation under COBRA for Dr. Macdonald and his eligible dependents ($14,819).
|
(3) |
Dr. Macdonald ceased employment with Edge on
May 15,
2018.
|
(4) |
Dr. Faleck ceased employment with Edge on December 31, 2018.
|
Name
|
Number of Securities
Underlying Unexercised
Options Exercisable
|
Number of Securities
Underlying Unexercised
Options Unexercisable
|
Option
Exercise Price
|
Grant Date
|
Expiration Date
|
Number of Restricted
Stock Award Shares that
have not Vested
|
Market Value of Restricted
Stock Award Shares that
have not Vested
|
||||||||||||||||
Brian A. Leuthner
(1) (2)
|
186,390
|
-
|
$
|
2.04
|
10/11/2013
|
10/11/2023
|
-
|
-
|
|||||||||||||||
69,440
|
-
|
$
|
8.28
|
3/27/2014
|
3/27/2024
|
-
|
-
|
||||||||||||||||
504,350
|
21,928
|
$
|
6.36
|
3/11/2015
|
3/11/2025
|
-
|
-
|
||||||||||||||||
162,916
|
67,084
|
$
|
6.99
|
2/16/2016
|
2/16/2026
|
-
|
-
|
||||||||||||||||
122,615
|
144,885
|
$
|
8.86
|
3/13/2017
|
3/13/2027
|
-
|
-
|
||||||||||||||||
-
|
280,000
|
$
|
14.98
|
3/1/2018
|
3/1/2028
|
-
|
-
|
||||||||||||||||
-
|
338,068
|
$
|
1.10
|
6/19/2018
(3)
|
6/19/2022
|
-
|
-
|
||||||||||||||||
-
|
-
|
-
|
8/14/2018
(4)
|
NA
|
169,032
|
$
|
54,090
|
||||||||||||||||
R. Loch Macdonald, M.D., PhD.
(1) (2)
|
75,505
|
-
|
$
|
2.04
|
10/11/2013
|
3/1/2027
|
-
|
-
|
|||||||||||||||
63,958
|
-
|
$
|
8.28
|
3/27/2014
|
3/27/2024
|
-
|
-
|
||||||||||||||||
109,642
|
7,309
|
$
|
6.36
|
3/11/2015
|
3/11/2025
|
-
|
-
|
||||||||||||||||
178,166
|
41,116
|
$
|
11.00
|
9/30/2015
|
9/30/2025
|
-
|
-
|
||||||||||||||||
60,202
|
24,798
|
$
|
6.99
|
2/16/2016
|
2/16/2026
|
-
|
-
|
||||||||||||||||
50,420
|
59,580
|
$
|
8.86
|
3/13/2017
|
3/13/2027
|
-
|
-
|
||||||||||||||||
-
|
20,000
|
$
|
1.10
|
6/19/2018
(3)
|
6/19/2022
|
-
|
-
|
||||||||||||||||
-
|
-
|
-
|
8/14/2018
(4)
|
NA
|
10,000
|
$
|
3,200
|
||||||||||||||||
Herbert J. Faleck
(1) (2)
|
148,341
|
-
|
$
|
8.28
|
3/27/2014
|
3/27/2024
|
-
|
-
|
|||||||||||||||
116,951
|
-
|
$
|
6.36
|
3/11/2015
|
3/11/2016
|
-
|
-
|
||||||||||||||||
77,914
|
32,086
|
$
|
6.99
|
2/16/2016
|
2/16/2026
|
-
|
-
|
||||||||||||||||
17,182
|
7,818
|
$
|
7.24
|
3/1/2016
|
3/1/2026
|
-
|
-
|
||||||||||||||||
50,420
|
59,580
|
$
|
0.00
|
3/13/2017
|
3/13/2027
|
-
|
-
|
||||||||||||||||
-
|
50,000
|
$
|
10.10
|
1/2/2018
|
1/2/2028
|
-
|
-
|
||||||||||||||||
-
|
90,000
|
$
|
14.98
|
3/1/2018
|
3/1/2028
|
-
|
-
|
||||||||||||||||
-
|
119,667
|
$
|
1.10
|
6/19/2018
(3)
|
6/19/2022
|
-
|
-
|
||||||||||||||||
-
|
-
|
-
|
8/14/2018
(4)
|
NA
|
59,833
|
$
|
19,147
|
||||||||||||||||
Andrew Saik
(1) (2)
|
58,336
|
141,664
|
$
|
10.73
|
11/1/2017
|
11/1/2027
|
-
|
-
|
|||||||||||||||
-
|
50,000
|
$
|
14.98
|
3/1/2018
|
3/1/2028
|
-
|
-
|
||||||||||||||||
-
|
166,001
|
$
|
1.10
|
6/19/2018
(3)
|
6/19/2022
|
-
|
-
|
||||||||||||||||
-
|
-
|
-
|
8/14/2018
(4)
|
NA
|
82,999
|
$
|
26,560
|
||||||||||||||||
W. Bradford Middlekauff
(1) (2)
|
63,328
|
16,672
|
$
|
14.92
|
11/16/2015
|
11/16/2025
|
-
|
-
|
|||||||||||||||
24,788
|
10,212
|
$
|
6.99
|
2/16/2016
|
2/16/2026
|
-
|
-
|
||||||||||||||||
24,065
|
28,435
|
$
|
8.86
|
3/13/2017
|
3/13/2027
|
-
|
-
|
||||||||||||||||
-
|
65,000
|
$
|
14.98
|
3/1/2018
|
3/1/2028
|
-
|
-
|
||||||||||||||||
-
|
99,534
|
$
|
1.10
|
6/19/2018
(3)
|
6/19/2022
|
-
|
-
|
||||||||||||||||
-
|
-
|
-
|
8/14/2018
(4)
|
NA
|
49,766
|
$
|
15,925
|
(1) |
Except as otherwise noted, options vest with respect to one-fourth of the underlying shares on the first anniversary of the grant date and in equal installments of 1⁄48 of
the underlying shares on each monthly anniversary of the grant date thereafter for the subsequent 36 months.
|
(2) |
Options granted after November 3, 2014 were granted under the Current Plan. Options granted prior to such date were granted under the Edge Therapeutics, Inc. 2012 Equity
Incentive Plan.
|
(3) |
Represents stock options granted in connection with the Retention Arrangements. These options vest on the earliest to occur of (i) the termination of the executive’s
employment with Edge other than for cause (as defined in the Current Plan), (ii) the consummation of a strategic transaction arising out of the strategic review discussed above and (iii) the one-year anniversary of the grant date.
|
(4) |
Represents RSUs granted in connection with the Retention Arrangements. These RSUs have the same vesting terms as those described in note (3) above relating to retention
stock options.
|
Upon Termination Without Cause or Resignation for
|
||||||||||||||||
Good Reason—No Change in Control
|
||||||||||||||||
Cash
Payment ($)
|
Accelerated
Equity Vesting
|
Other ($)
(1)
|
Total ($)
|
|||||||||||||
Brian A. Leuthner
|
|
795,000
|
|
|
-
|
|
38,105
|
|
833,105
|
|||||||
Herbert J. Faleck, D.O.
(2)
|
416,000
|
-
|
25,403
|
441,403
|
||||||||||||
Andrew Saik
|
370,000
|
-
|
25,403
|
395,403
|
||||||||||||
W. Bradford Middlekauff
|
347,700
|
-
|
25,403
|
373,103
|
(1) |
Reflects the value of COBRA premium reimbursements for the named executive officer and his eligible dependents.
|
(2) |
Mr. Faleck became entitled to these payments upon the termination of his employment on December 31, 2018.
|
Upon Termination Without Cause or Resignation for
|
||||||||||||||||
Good Reason—With Change in Control
|
||||||||||||||||
Cash
Payment ($)
|
Accelerated
Equity Vesting ($)
(1)
|
Other ($)
(2)
|
Total ($)
|
|||||||||||||
Brian A.Leuthner
|
|
1,510,500
|
|
4,041,238
|
|
38,105
|
|
5,589,843
|
||||||||
Herbert J. Faleck, D.O.
|
416,000
|
1,770,053
|
25,403
|
2,211,456
|
||||||||||||
Andrew Saik
|
370,000
|
1,662,394
|
25,403
|
2,057,797
|
||||||||||||
W. Bradford Middlekauff
|
347,700
|
1,036,037
|
25,403
|
1,409,140
|
(1) |
Assumes all outstanding options vest upon termination.
|
(2) |
Reflects the value of COBRA premium reimbursements for the named executive officer and his eligible dependents.
|
Upon A Change in Control
—
No Termination of Employment
|
||||||||||||||||
Cash
Payment ($)
|
Accelerated
Equity Vesting ($)
(1)
|
Other ($)
|
Total ($)
|
|||||||||||||
Brian A. Leuthner
|
|
-
|
|
1,361,534
|
|
-
|
|
1,361,534
|
||||||||
Herbert J. Faleck, D.O.
|
-
|
1,072,108
|
-
|
1,072,108
|
||||||||||||
Andrew Saik
|
-
|
1,126,718
|
-
|
1,126,718
|
||||||||||||
W. Bradford Middlekauff
|
-
|
402,694
|
-
|
402,694
|
(1) |
Options granted in 2018 are not included in this column because such options have
“
double trigger
”
vesting.
|
Name
|
Fees Earned
or Paid in Cash
($)
|
Option
Awards
($)
(1)
|
Total
($)
|
|||||||||
Sol Barer, Ph.D.
|
92,500
|
40,175
|
132,675
|
|||||||||
Isaac Blech
|
41,750
|
20,088
|
61,838
|
|||||||||
Kurt Conti
(2)
|
21,500
|
-
|
21,500
|
|||||||||
Rose Crane
|
51,750
|
20,088
|
71,838
|
|||||||||
James I. Healy, M.D., Ph.D.
(3)
|
21,500
|
-
|
21,500
|
|||||||||
James Loughlin
|
54,250
|
20,088
|
74,338
|
|||||||||
Liam Ratcliffe, M.D., Ph.D.
|
44,500
|
20,088
|
64,588
|
|||||||||
Robert Spiegel, M.D.
|
69,250
|
20,088
|
89,338
|
(1)
|
The amounts shown in this column do not reflect actual compensation received by our directors. The amounts reflect
the grant date fair value of option awards and are calculated in accordance with the provisions of FASB Accounting Standards Codification Topic 718 Compensation — Stock Options (“ASC Topic 718”), and assume no forfeiture rate
derived in the calculation of the grant date fair value of these awards. Assumptions used in calculating the value of these awards are included in Note 7, “Stock Options” in the notes to Edge’s financial statements included in
this Annual Report. The director will only realize compensation to the extent the trading price of Edge’s common stock is greater than the exercise price of such stock options at the time such options are exercised.
|
(2)
|
Mr. Conti resigned from the Edge Board on June 19, 2018.
|
(3)
|
Mr. Healy ceased to serve on the Edge Board following the 2018 annual meeting of the stockholders held on June 19,
2018.
|
Name
|
Number of Options
|
|||
Sol Barer, Ph.D.
|
720,836
|
|||
Isaac Blech
|
828,950
|
|||
Rose Crane
|
60,000
|
|||
James Loughlin
|
119,939
|
|||
Liam Ratcliffe, M.D., Ph.D.
|
75,000
|
|||
Robert Spiegel, M.D.
|
120,668
|
● |
each person, entity or group known to Edge to beneficially own more than 5% of its common stock;
|
● |
each of Edge
’
s named executive officers;
|
● |
each of Edge
’
s directors; and
|
● |
all of Edge
’
s executive officers and directors as a group.
|
Beneficial Ownership
|
||||||||
Name of Beneficial Owner
|
Shares
|
%
|
||||||
Greater than 5% Stockholders
:
|
||||||||
Sofinnova Venture Partners IX, L.P.
(1)
|
2,852,711
|
9.07
|
||||||
Entities affiliated with New Leaf Ventures III, L.P.
(2)
|
2,379,668
|
7.57
|
||||||
Named Executive Officers and
Directors
:
|
||||||||
Sol Barer, Ph.D.
(3)
|
1,318,911
|
4.19
|
||||||
Isaac Blech
(4)
|
798,950
|
2.54
|
||||||
Brian Leuthner
(5)
|
1,622,719
|
5.16
|
||||||
Rosemary Crane
(6)
|
9,900
|
0.03
|
||||||
James Loughlin
(7)
|
115,564
|
0.37
|
||||||
R. Loch Macdonald, M.D., Ph.D.
(8)
|
1,165,194
|
3.70
|
||||||
Liam Ratcliffe, M.D., Ph.D.
(2)
|
2,379,668
|
7.57
|
||||||
Robert Spiegel, M.D., FACP
(9)
|
129,329
|
0.41
|
||||||
W. Bradford Middlekauff
(10)
|
145,406
|
0.46
|
||||||
Andrew Saik
(11)
|
79,172
|
0.25
|
||||||
All current executive officers and directors as a group 10 persons)
|
7,764,816
|
24.69
|
* |
all of Edge
’
s executive officers and directors as a group.
|
(1) |
Represents shares held directly by Sofinnova Venture Partners IX, L.P., or SVP IX. Dr. James Healy, a former director of Edge together with Dr. Michael F. Powell and Dr.
Anand Mehra, are the managing members of Sofinnova Management IX, L.L.C., the general partner of SVP IX, and as such, may be deemed to share voting and investment power with respect to such shares. Dr. Healy disclaims beneficial
ownership. The mailing address of SVP IX is c/o Sofinnova Ventures, Inc., 3000 Sand Hill Road, Bldg. 4, Suite 250, Menlo Park, CA 94025.
|
(2) |
New Leaf Venture Associates III, L.P., or NLVA-III LP, is the general partner of NLV-III and New Leaf BPO Associates I, L.P., or BPOA-I LP, is the general partner of New
Leaf Biopharma Opportunities I, L.P., or BPO-I. New Leaf Venture Management III, L.L.C., or NLVM-III LLC, is the General Partner of both NLVA-III LP and BPOA-I LP. Ronald M. Hunt, Vijay K. Lathi, and Liam Ratcliffe are individual
members of NLVM-III LLC, or collectively, the Individual Members. NLVA-III LP, BPOA-I LP and NLVM-III LLC disclaim beneficial ownership of such shares, except to the extent of their pecuniary interest therein. As one of three individual
members, each of the Individual Members disclaims beneficial ownership over the shares, and in all events disclaims pecuniary interest except to the extent of his economic interest. The mailing address of the beneficial owner is Times
Square Tower, 7 Times Square, Suite 3502, New York, NY 10036.
|
(3) |
Includes 658,075 shares owned of record by Meryl Barer, Dr. Barer’s wife, all of which she may be deemed to have beneficial ownership of, and 660,836 shares for Dr. Barer
subject to stock options that are currently exercisable within 60 days of December 31, 2018.
|
(4) |
Represents shares that are subject to outstanding options held by Mr. Blech that are currently exercisable with 60 days of December 31, 2018.
|
(5) |
Includes 162,000 shares owned of record by Cristina Leuthner, Mr. Leuthner’s wife, 78,730 shares held directly by Mr. Leuthner and 223,622 shares held in trust for the
Leuthner children, to which Mr. Leuthner disclaims beneficial ownership, and 1,158,367 shares subject to outstanding options held by Mr. Leuthner that are currently exercisable with 60 days of December 31, 2018.
|
(6) |
Represents shares that are subject to outstanding options held by Ms. Crane that are currently exercisable within 60 days of December 31, 2018.
|
(7) |
Includes 25,625 shares held directly by Mr. Loughlin and 89,939 shares subject to outstanding options held by Mr. Loughlin that are exercisable within 60 days of December
31, 2018.
|
(8) |
Includes 577,730 shares held directly by Dr. Macdonald and 587,464 shares subject to outstanding options held by Dr. Macdonald that are currently exercisable with 60 days
of December 31, 2018.
|
(9) |
Includes 38,661 shares held directly by Dr. Spiegel and 90,668 shares subject to outstanding options held by Dr. Spiegel that are exercisable within 60 days of December 31,
2018.
|
(10) |
Includes 10,000 shares held directly by Mr. Middlekauff and 135,409 shares subject to outstanding options held by Mr. Middlekauff that are exercisable within 60 days of
December 31, 2018.
|
(11) |
Represents shares that are subject to outstanding options held by Mr. Saik that are currently exercisable within 60 days of December 31, 2018.
|
● |
The amounts exceeded or will exceed $120,000; and
|
● |
Any of the directors, executive officers or holders of more than 5% of the respective capital stock, or any member of the immediate family of any of the foregoing persons,
had or will have a direct or indirect material financial interest.
|
Recipient
|
Title
|
Stock Options with a
Grant Date of
June 19, 2018
|
RSUs with a
Grant Date of
August 14, 2018
|
Cash
Compensation
|
||||||||||
Brian A. Leuthner
|
President and Chief Executive Officer
|
338,068
|
169,032
|
$
|
318,000
|
|||||||||
Herbert J. Faleck
|
Former Chief Medical Officer
|
119,667
|
59,833
|
$
|
187,200
|
|||||||||
Andrew Saik
|
Chief Financial Officer
|
166,001
|
82,999
|
$
|
166,500
|
|||||||||
W. Bradford Middlekauff
|
Senior Vice President, General Counsel and Secretary
|
99,534
|
49,766
|
$
|
157,470
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Audit fees
|
$
|
398,000
|
$
|
398,000
|
||||
Audit-related fees
|
58,450
|
15,000
|
||||||
Tax fees |
–
|
97,650
|
||||||
All Other Fees |
–
|
–
|
||||||
Total
|
$
|
456,450
|
$
|
510,650
|
(a) |
The following documents are filed as part of this report:
|
Exhibit
Number
|
Exhibit Description
|
|
2.1
|
Agreement and Plan of Merger and Reorganization
, dated November 23, 2018, by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc. and PDS
Biotechnology Corporation
(filed as exhibit 2.1 to the Company’s Current Report on Form 8-K filed on November 26, 2018, and incorporated by reference
herein).
|
|
2.2
|
Amendment No. 1 to Agreement and Plan of Merger and Reorganization
, dated January 24, 2019, by and among Edge Therapeutics, Inc., Echos
Merger Sub, Inc. and PDS Biotechnology Corporation
(filed as exhibit 2.1 to the
Company’s Current Report on Form 8-K filed on January 30, 2019, and incorporated by reference herein).
|
|
2.3
|
Form of Support Agreement
by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc., PDS Biotechnology Corporation and certain of PDS
Biotechnology Corporation’s directors, officers and stockholders
(filed as exhibit 2.2 to the Company’s Current Report on Form 8-K filed on November 26,
2018, and incorporated by reference herein).
|
|
2.4
|
Form of Support Agreement
by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc., PDS Biotechnology Corporation and certain of Edge
Therapeutics, Inc.’s directors, officers and stockholders
(filed as exhibit 2.3 to the Company’s Current Report on Form 8-K filed on November 26, 2018, and
incorporated by reference herein).
|
|
3.1
|
Eighth 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
).
|
|
4.1
|
Form of Certificate of Common Stock.
(filed as exhibit 4.1 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
).
|
|
4.2
|
Warrant to Purchase 16,667 Shares of Capital Stock Issued to New Jersey Economic Development Authority, dated as of May 3, 2010.
(filed as
exhibit 4.2 to the Company’s Registration Statement on Form S-1 (File No. 333- 206416) filed on September 21, 2015, and incorporated by reference herein
).
|
|
4.3
|
First Amendment to Warrant Issued to New Jersey Economic Development Authority, dated October 9, 2013
(filed as exhibit 4.3 to the Company’s
Registration Statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
)
.
|
|
4.4
|
Form of Warrant Issued to Series B-1 Stockholders.
(filed as exhibit 4.4 to the Company’s Registration Statement on Form S-1 (File No. 333-
206416) filed on August 14, 2015, and incorporated by reference herein
).
|
|
4.5
|
Form of Warrant to Purchase Series C Preferred Stock issued to Maxim Group LLC.
(filed as exhibit 4.5 to the Company’s Registration Statement on
Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
).
|
|
4.6
|
Warrant Agreement, dated as of August 28, 2014, by and between the Company and Hercules.
(filed as exhibit 4.6 to the Company’s Registration
Statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
).
|
|
4.7
|
Form of Warrant to Purchase Series C-1 Preferred Stock issued to Maxim Group LLC.
(filed as exhibit 4.7 to the Company’s Registration Statement
on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
).
|
|
4.8
|
Investors’ Rights Agreement, dated as of April 6, 2015, by and among the Company and the Investors named therein.
(filed as exhibit 4.8 to the
Company’s Registration Statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
).
|
|
4.9
|
Warrant to Purchase 18,000 Shares of Common Stock issued to Maxim Partners LLC, dated as of October 6, 2015.
(filed as exhibit 4.1 to the Company’s
Quarterly Report on Form 10-Q filed on November 6, 2015, and incorporated by reference herein
).
|
10.1 *
|
Licensing Agreement by and between the Company and Evonik Industries (as successor in interest to SurModics Pharmaceuticals, Inc.), dated as of October 20, 2010.
(filed as exhibit 10.1 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 *
|
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
).
|
|
10.3 **
|
Amended and Restated Master Formulation Development Agreement, by and between the Company and Oakwood Laboratories LLC, dated as of June 30, 2017
(filed as
exhibit 10.1 to the Company’s Form 10-Q for the quarter ended June 30, 2017 and incorporated by reference herein)
.
|
|
10.4 **
|
Manufacturing and Supply Agreement, by and between the Company and Oakwood Laboratories LLC, dated as of June 30, 2017
(filed as Exhibit 10.2 to the
Company’s Form 10-Q for the quarter ended June 30, 2017 and incorporated by reference herein).
|
|
10.5**+
|
Edge Therapeutics, Inc. 2010 Equity Incentive Plan and forms of agreement thereunder.
(filed as exhibit 10.2 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
).
|
|
10.6+
|
Amendment to the Edge Therapeutics, Inc. 2010 Equity Incentive Plan, dated June 30, 2014
(filed as exhibit 10.11 to the Company’s Registration
Statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
)
.
|
|
10.7+
|
Edge Therapeutics, Inc. 2012 Equity Incentive Plan and forms of agreement thereunder.
(filed as exhibit 10.3 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
).
|
|
10.8+
|
Edge Therapeutics, Inc. 2014 Equity Incentive Plan and forms of agreement thereunder.
(filed as exhibit 10.4 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
).
|
|
10.9+
|
Second Amended and Restated Employment Agreement by and between Brian A. Leuthner and the Company dated as of June 10, 2015.
(filed as exhibit
10.5 to the Company’s Registration Statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
).
|
|
10.10+
|
Second Amended and Restated Employment Agreement by and between Albert N. Marchio, II and the Company dated as of June 8, 2015
(filed as exhibit
10.8 to the Company’s Registration Statement on Form S-1 (File No. 333- 206416) filed on August 14, 2015, and incorporated by reference herein
)
.
|
|
10.11+
|
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
)
.
|
|
10.12+
|
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
)
.
|
|
10.13+
|
Executive Employment Agreement by and between W. Bradford Middlekauff and the Company dated as of October 30, 2015
(filed as exhibit 10.1 to the
Company’s Current Report on Form 8-K filed on November 5, 2015, and incorporated by reference herein
).
|
|
10.14+
|
Employment Agreement by and between Daniel Brennan and the Company, dated as of October 17, 2016
(filed as exhibit 10.1 to the Company’s Current Report on
Form 8-K filed on October 18, 2016, and incorporated by reference herein).
|
|
10.15+
|
Executive Employment Agreement by and between Andrew Saik and the Company dated as of October 31, 2017
(filed as exhibit 10.1 to the Company’s
Current Report on Form 8-K filed November 1, 2017, and incorporated by reference herein).
|
|
10.15
|
Form of Indemnification Agreement for officers and directors
(filed as exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File
No. 333-206416) filed on August 14, 2015, and incorporated by reference herein).
|
|
10.17
|
Form of Executive Stock Option Agreement
(filed
as Exhibit 10.17 to the Company’s Annual Report on Form 10-K filed on March 2, 2017, and incorporated by reference herein)
|
10.18
|
Form of Employee Stock Option Agreement
(filed
as Exhibit 10.18 to the Company’s Annual Report on Form 10-K filed on March 2, 2017, and incorporated by reference herein)
|
|
10.19
|
Lease, dated February 18, 2016, between The Connell Company and Edge Therapeutics, Inc.
(filed as exhibit 10.1 to the Company’s Quarterly Report on Form
10-Q filed on May 3, 2016, and incorporated by reference herein
).
|
|
10.20
|
Letter Agreement, dated February 3, 2019, by and among Edge Therapeutics, Inc., PDS Biotechnology Corporation and Brian A. Leuthner
(filed as
exhibit 10.1 to the Company’s Current Report on Form 8-K filed on February 4, 2019, and incorporated by reference herein)
|
|
23.1
|
Consent of KPMG LLP
(filed herewith).
|
|
31.1
|
||
31.2
|
||
32.1
(1)
|
||
32.2
(1)
|
||
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.
|
** |
Confidential Treatment has been requested with respect to certain portions of this Exhibit. Omitted portions have been filed separately with the Securities and Exchange
Commission.
|
Edge Therapeutics, Inc.
|
||
February 21, 2019
|
By:
|
/s/ Brian A. Leuthner
|
Brian A. Leuthner
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
||
February 21, 2019
|
By:
|
/s/ Andrew Saik
|
Andrew Saik
|
||
Chief Financial Officer
|
||
(Principal Financial Officer)
|
Signature
|
Title
|
Date
|
||
/s/ Brian A. Leuthner
|
President and Chief Executive Officer and Director
|
February 21, 2019
|
||
Brian A. Leuthner
|
(Principal Executive Officer)
|
|||
/s/ Andrew Saik
|
Chief Financial Officer
|
February 21, 2019
|
||
Andrew Saik
|
(Principal Financial Officer)
|
|||
/s/ Sol Barer
|
Chairman, Board of Directors
|
February 21, 2019
|
||
Sol Barer, Ph.D.
|
||||
/s/ Isaac Blech
|
Vice Chairman, Board of Directors
|
February 21, 2019
|
||
Isaac Blech
|
||||
/s/ Rosemary A. Crane
|
Director
|
February 21, 2019
|
||
Rosemary A. Crane
|
||||
/s/ James Loughlin
|
Director
|
February 21, 2019
|
||
James Loughlin
|
||||
/s/ R. Loch Macdonald
|
Director
|
February 21, 2019
|
||
R. Loch Macdonald, M.D., Ph.D.
|
||||
/s/ Liam Ratcliffe
|
Director
|
February 21, 2019
|
||
Liam Ratcliffe, M.D., Ph.D.
|
||||
/s/ Robert Spiegel
|
Director
|
February 21, 2019
|
||
Robert Spiegel, M.D.
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Operating expenses:
|
||||||||
Research and development expenses
|
$
|
16,068,769
|
$
|
34,311,650
|
||||
General and administrative expenses
|
14,291,008
|
17,654,970
|
||||||
Restructuring expenses
|
9,914,209
|
–
|
||||||
Impairment charges
|
2,822,581
|
–
|
||||||
Total operating expenses
|
43,096,567
|
51,966,620
|
||||||
Loss from operations
|
(43,096,567
|
)
|
(51,966,620
|
)
|
||||
Other income (expense):
|
||||||||
Interest income
|
871,879
|
700,903
|
||||||
Interest expense
|
(1,425,255
|
)
|
(2,180,143
|
)
|
||||
Loss before income taxes
|
(43,649,943
|
)
|
(53,445,860
|
)
|
||||
Benefit for income taxes
|
2,781,937
|
2,586,057
|
||||||
Net loss and comprehensive loss
|
$
|
(40,868,006
|
)
|
$
|
(50,859,803
|
)
|
||
Loss per share attributable to common stockholders basic and diluted
|
$
|
(1.31
|
)
|
$
|
(1.67
|
)
|
||
Weighted average common shares outstanding basic and diluted
|
31,242,176
|
30,393,952
|
Common Stock
|
||||||||||||||||||||
Shares
Issued
|
Amount
|
Additional
Paid-in Capital
|
Deficit
Accumulated
|
Total
|
||||||||||||||||
Balance - December 31, 2016
|
28,918,516
|
$
|
9,756
|
$
|
190,341,769
|
$
|
(101,074,968
|
)
|
$
|
89,276,557
|
||||||||||
Stock based compensation expense
|
–
|
–
|
6,182,841
|
–
|
6,182,841
|
|||||||||||||||
Issuance of common stock, net of issuance costs
|
1,800,000
|
594
|
17,382,349
|
–
|
17,382,943
|
|||||||||||||||
Issuance of common stock from exercise of stock options
|
35,366
|
12
|
118,176
|
–
|
118,188
|
|||||||||||||||
Issuance of common stock from exercise of warrants
|
94,200
|
31
|
53,118
|
–
|
53,149
|
|||||||||||||||
Issuance of common stock from 401K match
|
21,123
|
7
|
217,529
|
–
|
217,536
|
|||||||||||||||
Cumulative-effect of new share-based compensation guidance
|
–
|
–
|
13,588
|
(13,588
|
)
|
–
|
||||||||||||||
Net loss
|
–
|
–
|
–
|
(50,859,803
|
)
|
(50,859,803
|
)
|
|||||||||||||
Balance - December 31, 2017
|
30,869,205
|
10,400
|
214,309,370
|
(151,948,359
|
)
|
62,371,411
|
||||||||||||||
Stock based compensation expense
|
–
|
–
|
7,469,441
|
–
|
7,469,441
|
|||||||||||||||
Issuance of common stock from exercise of stock options
|
198,300
|
65
|
721,130
|
–
|
721,195
|
|||||||||||||||
Issuance of common stock from exercise of warrants
|
175,999
|
58
|
(58
|
)
|
–
|
–
|
||||||||||||||
Issuance of common stock from vesting of RSUs
|
91,432
|
30
|
(30
|
)
|
–
|
–
|
||||||||||||||
Issuance of common stock from 401K match
|
115,053
|
38
|
145,129
|
–
|
145,167
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(40,868,006
|
)
|
(40,868,006
|
)
|
|||||||||||||
Balance - December 31, 2018
|
31,449,989
|
$
|
10,591
|
$
|
222,644,982
|
$
|
(192,816,365
|
)
|
$
|
29,839,208
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(40,868,006
|
)
|
$
|
(50,859,803
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
7,469,442
|
6,182,841
|
||||||
Stock-based 401K company common match
|
145,167
|
217,536
|
||||||
Depreciation expense
|
174,347
|
182,918
|
||||||
Impairment of machinery and equipment
|
2,822,581
|
–
|
||||||
Amortization of debt discount
|
1,039
|
32,869
|
||||||
Amortization of debt issuance costs
|
125,355
|
108,407
|
||||||
Non-cash interest expense
|
405,278
|
363,909
|
||||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(18,909
|
)
|
(32,099
|
)
|
||||
Accounts payable
|
(3,969,686
|
)
|
898,101
|
|||||
Accrued expenses
|
(5,003,087
|
)
|
2,208,490
|
|||||
Restructuring reserve
|
5,563,186
|
–
|
||||||
Net cash used in operating activities
|
(33,153,293
|
)
|
(40,696,831
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
–
|
(188,721
|
)
|
|||||
Net cash used in investing activities
|
–
|
(188,721
|
)
|
|||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of debt
|
–
|
5,000,000
|
||||||
Proceeds from exercise of stock options
|
721,195
|
118,188
|
||||||
Proceeds from exercise of warrants
|
–
|
53,149
|
||||||
Payments for debt back end fees
|
(990,000
|
)
|
–
|
|||||
Repayment of debt
|
(20,000,000
|
)
|
–
|
|||||
Proceeds from issuance of common stock, net of underwriting costs
|
–
|
17,382,943
|
||||||
Net cash (used) provided by financing activities
|
(20,268,805
|
)
|
22,554,280
|
|||||
Net decrease in cash
|
(53,422,098
|
)
|
(18,331,272
|
)
|
||||
Cash and cash equivalents at beginning of period
|
88,067,647
|
106,398,919
|
||||||
Cash and cash equivalents at end of period
|
$
|
34,645,549
|
$
|
88,067,647
|
||||
Supplemental disclosure of cash flow information:
|
||||||||
Cash paid for:
|
||||||||
Interest
|
$
|
1,051,167
|
$
|
1,635,562
|
||||
● |
Pursue another strategic transaction similar to the merger. Edge may resume its process of evaluating other companies interested in pursuing a strategic transaction with
Edge and, if a candidate is identified, focus its attention on negotiating and completing such a transaction with such candidate.
|
● |
Dissolve and liquidate its assets. If Edge is unable, or does not believe that it is able, to find a suitable candidate for another strategic transaction, Edge may dissolve
and liquidate its assets. In the event of dissolution, Edge would be required to pay all of its debts and contractual obligations and to set aside certain reserves for potential future claims. If Edge dissolves and liquidates its
assets, there can be no assurance as to the amount or timing of available cash that will remain for distribution to Edge’ stockholders after paying Edge’ debts and other obligations and setting aside funds for its reserves.
|
Restructuring reserve at December 31, 2017
|
$
|
–
|
||
Initial restructuring charge
|
6,276,563
|
|||
Incurred legal fees
|
1,447,079
|
|||
Severance revisions
|
259,529
|
|||
Retention compensation
|
1,201,568
|
|||
Restructuring expenses to date (1)
|
9,184,739
|
|||
Payment of legal fees
|
(493,404
|
)
|
||
Payment of retention compensation
|
(56,925
|
)
|
||
Payment of advisor fees
|
(500,000
|
)
|
||
Payment of severance benefits
|
(2,571,224
|
)
|
||
Restructuring reserve as of December 31, 2018
|
$
|
5,563,186
|
(1) |
Excludes non-cash stock based retention compensation of $729,470 expensed to date through restructuring expenses.
|
(A) |
Use of estimates:
|
(B) |
Significant risks and uncertainties:
|
(C) |
Cash equivalents and concentration of cash balance:
|
(D) |
Property and equipment:
|
(E) |
Research and development:
|
(F) |
Patent costs:
|
(G) |
Stock-based compensation:
|
(H) |
Net loss per common share:
|
As of December 31,
|
||||||||
2018
|
2017
|
|||||||
Stock options to purchase Common Stock
|
7,043,825
|
6,462,795
|
||||||
Unvested Restricted Stock Units
|
509,962
|
-
|
||||||
Warrants to purchase Common Stock
|
78,596
|
374,653
|
||||||
Total
|
7,632,383
|
6,837,448
|
(I) |
Income taxes:
|
(J) |
Fair value of financial instruments:
|
● |
Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level
1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.
|
● |
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of
similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation
methodologies.
|
● |
Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models,
discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.
|
(K) |
Subsequent events:
|
(L) |
New accounting standards not yet adopted:
|
● |
The Company recognized $84,786 of tax benefit along with a full valuation allowance as of the adoption date related to the historical excess tax benefits from historical
option exercises related to employee equity award activity.
|
● |
The Company elected to recognize forfeitures as they occur. The cumulative effect adjustment as a result of the adoption of this amendment on a modified retrospective basis
was not material.
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Total
|
Quoted Prices in
Active Markets
(Level 1)
|
Quoted Prices in
Inactive Markets
(Level 2)
|
Significant
Unobservable Inputs
(Level 3)
|
|||||||||||||
As of December 31, 2018:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
34,645,549
|
$
|
34,645,549
|
$
|
–
|
$
|
–
|
||||||||
As of December 31, 2017:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
88,067,647
|
$
|
88,067,647
|
$
|
–
|
$
|
–
|
December 31,
|
||||||||
2018
|
2017
|
|||||||
Furniture and equipment
|
$
|
439,620
|
$
|
564,596
|
||||
Leasehold Improvements
|
438,996
|
438,996
|
||||||
Construction in Process
|
-
|
2,725,569
|
||||||
878,616
|
3,729,161
|
|||||||
Less accumulated depreciation
|
(451,664
|
)
|
(305,281
|
)
|
||||
Property and equipment, net
|
$
|
426,952
|
$
|
3,423,880
|
December 31,
|
||||||||
2018
|
2017
|
|||||||
Accrued research and development costs
|
$
|
76,600
|
$
|
2,857,025
|
||||
Accrued professional fees
|
69,083
|
267,646
|
||||||
Accrued compensation
|
27,405
|
1,886,638
|
||||||
Accrued other
|
213,074
|
385,896
|
||||||
Deferred rent
|
32,957
|
25,000
|
||||||
Total
|
$
|
419,119
|
$
|
5,422,205
|
Issue Date
|
25% Vesting Date
|
Executive
|
Number of Options
|
|||
November 16, 2015
|
October 30, 2016
|
SVP, General Counsel and Secretary
|
80,000
|
|||
November 1, 2017
|
October 31, 2018
|
Chief Financial Officer
|
200,000
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Stock-Based Compensation
|
||||||||
Research and development
|
$
|
2,503,889
|
$
|
2,687,975
|
||||
General and administrative
|
4,236,083
|
3,494,866
|
||||||
Retention compensation
|
729,470
|
–
|
||||||
Total
|
$
|
7,469,442
|
$
|
6,182,841
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Weighted
Average
|
Weighted
Average
|
|||||||
Volatility
|
86.33
|
%
|
88.87
|
%
|
||||
Risk-Free Interest Rate
|
2.23
|
%
|
1.88
|
%
|
||||
Expected Term in Years
|
6.00
|
6.00
|
||||||
Dividend Rate
|
0.00
|
%
|
0.00
|
%
|
||||
Fair Value of Option on Grant Date
|
$
|
5.08
|
$
|
6.93
|
Number
of Shares
|
Weighted Average
Exercise Price
|
Weighted Average Remaining
Contractual Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at January 1, 2017
|
5,316,511
|
$
|
5.84
|
|||||||||||||
Granted
|
1,365,400
|
9.39
|
||||||||||||||
Exercised
|
(35,366
|
)
|
3.34
|
|||||||||||||
Forfeited
|
(183,750
|
)
|
9.46
|
|||||||||||||
Options outstanding at December 31, 2017
|
6,462,795
|
$
|
6.50
|
7.13
|
$
|
20,467,335
|
||||||||||
Vested and expected to vest at December 31, 2017
|
6,462,795
|
$
|
6.50
|
7.13
|
$
|
20,467,335
|
||||||||||
Exercisable at December 31, 2017
|
4,066,066
|
$
|
5.14
|
6.21
|
$
|
18,100,589
|
||||||||||
Options outstanding at December 31, 2017
|
6,462,795
|
$
|
6.50
|
|||||||||||||
Granted
|
2,322,906
|
7.52
|
||||||||||||||
Exercised
|
(198,300
|
)
|
3.64
|
|||||||||||||
Forfeited
|
(1,543,576
|
)
|
10.30
|
|||||||||||||
Options outstanding at December 31, 2018
|
7,043,825
|
$
|
6.09
|
5.84
|
$
|
3,977
|
||||||||||
Vested and expected to vest at December 31, 2018
|
7,043,825
|
$
|
6.09
|
5.84
|
$
|
3,977
|
||||||||||
Exercisable at December 31, 2018
|
5,001,465
|
$
|
5.71
|
5.67
|
$
|
3,977
|
Number
of RSUs
|
Weighted Average
Grant Price
|
|||||||
RSUs outstanding at December 31, 2017
|
–
|
$
|
–
|
|||||
Granted
|
601,394
|
0.85
|
||||||
Released
|
(91,432
|
)
|
0.85
|
|||||
Forfeited
|
–
|
–
|
||||||
RSUs outstanding at December 31, 2018
|
509,962
|
$
|
0.85
|
Year Ended December 31,
|
||||||||
2018
|
2017
|
|||||||
Federal statutory rate
|
21.0
|
%
|
34.0
|
%
|
||||
State taxes
|
0.4
|
%
|
1.1
|
%
|
||||
Change in Statutory Rate
|
–
|
(25.6
|
)%
|
|||||
Permanent differences
|
(5.4
|
)%
|
(11.0
|
)%
|
||||
Research and development
|
6.3
|
%
|
21.2
|
%
|
||||
State taxes/ sale of NOL
|
6.4
|
%
|
4.8
|
%
|
||||
Valuation allowance
|
(22.3
|
)%
|
(19.7
|
)%
|
||||
Effective tax rate
|
6.4
|
%
|
4.8
|
%
|
December 31,
|
||||||||
2018
|
2017
|
|||||||
Federal net operating losses
|
$
|
27,011,760
|
$
|
21,312,121
|
||||
State net operating losses
|
1,929,997
|
2,268,249
|
||||||
Stock options
|
1,847,546
|
1,608,750
|
||||||
Federal tax credit
|
26,815,998
|
24,060,243
|
||||||
State tax credits
|
506,752
|
384,740
|
||||||
Amortization
|
229,065
|
612,878
|
||||||
Accrued expense
|
813,073
|
7,027
|
||||||
Depreciation
|
826,109
|
18,498
|
||||||
Other
|
17,993
|
12,501
|
||||||
Total gross deferred tax assets
|
59,998,293
|
50,285,007
|
||||||
Less valuation allowance
|
(59,998,293
|
)
|
(50,285,007
|
)
|
||||
Net deferred tax assets
|
$
|
–
|
$
|
–
|
Year Ended December 31,
|
||||
2019
|
$
|
604,541
|
||
2020
|
603,371
|
|||
2021
|
530,385
|
|||
2022 and after
|
–
|
|||
Total minimum payments required
|
$
|
1,738,297
|
1. |
I have reviewed this Annual Report on Form 10-K of Edge Therapeutics, Inc. for the year ended December 31, 2018;
|
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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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) |
Designed
such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles
;
|
c) |
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
|
d) |
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 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: February 21, 2019
|
/s/ Brian A. Leuthner
|
Brian A. Leuthner
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1. |
I have reviewed this Annual Report on Form 10-K of Edge Therapeutics, Inc. for the year ended December 31, 2018;
|
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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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) |
Designed
such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles
;
|
c) |
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
|
d) |
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 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: February 21, 2019
|
/s/ Andrew Saik
|
Andrew Saik
|
|
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: February 21, 2019
|
/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: February 21, 2019
|
/s/ Andrew Saik
|
Andrew Saik
|
|
Chief Financial Officer
|
|
(Principal Financial Officer)
|