☒ |
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
|
PDS Biotechnology Corporation
|
||
(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)
|
(Former name, former address and former fiscal year, if changed since last report)
|
Large accelerated filer
☐
|
Accelerated filer
☐
|
Non-accelerated filer
☒
|
Smaller Reporting Company
☒
|
Emerging growth company
☒
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
||
Common Stock, par value $0.00033 per share
|
PDSB
|
Nasdaq Capital Market
|
Page
|
|||
4
|
|||
5
|
|||
6
|
|||
8
|
|||
9
|
|||
20
|
|||
27
|
|||
27
|
|||
28
|
|||
28
|
|||
28
|
|||
32
|
|||
32
|
|||
32
|
|||
32
|
|||
32
|
|||
33
|
|||
34
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
1,886,934
|
$
|
168,606
|
$
|
2,916,937
|
$
|
369,744
|
||||||||
General and administrative expenses
|
2,383,972
|
398,425
|
6,289,848
|
934,226
|
||||||||||||
|
||||||||||||||||
Total operating expenses
|
4,270,906
|
567,031
|
9,206,785
|
1,303,970
|
||||||||||||
|
||||||||||||||||
Loss from operations
|
(4,270,906
|
)
|
(567,031
|
)
|
(9,206,785
|
)
|
(1,303,970
|
)
|
||||||||
|
||||||||||||||||
Other income (expense):
|
||||||||||||||||
Gain on bargain purchase
|
209,449
|
–
|
11,939,331
|
–
|
||||||||||||
Interest income
|
175,605
|
4
|
198,907
|
10
|
||||||||||||
Interest expense
|
–
|
(804
|
)
|
(606
|
)
|
(1,763
|
)
|
|||||||||
|
||||||||||||||||
Net income (loss) and comprehensive income (loss)
|
(3,885,852
|
)
|
(567,831
|
)
|
2,930,847
|
(1,305,723
|
)
|
|||||||||
|
||||||||||||||||
Net income (loss) per share, basic
|
(0.75
|
)
|
(0.17
|
)
|
0.66
|
(0.41
|
)
|
|||||||||
Net income (loss) per share, diluted
|
$
|
(0.75
|
)
|
$
|
(0.17
|
)
|
$
|
0.52
|
$
|
(0.41
|
)
|
|||||
|
||||||||||||||||
Weighted average common shares outstanding, basic
|
5,175,837
|
3,338,214
|
4,466,025
|
3,170,804
|
||||||||||||
Weighted average common shares outstanding, diluted
|
5,175,837
|
3,338,214
|
5,677,360
|
3,170,804
|
Common Stock
|
Additional
|
Accumulated
|
Total
|
|||||||||||||||||
|
Shares Issued
|
Amount
|
Paid-in Capital
|
Deficit
|
Equity (Deficit)
|
|||||||||||||||
Balance - March 31, 2018
|
3,333,398
|
$
|
1,100
|
$
|
18,555,004
|
$
|
(18,840,510
|
)
|
$
|
(284,406
|
)
|
|||||||||
Stock-based compensation expense
|
–
|
–
|
630
|
–
|
630
|
|||||||||||||||
Issuance of common stock, net of issuance costs
|
7,745
|
3
|
43,997
|
–
|
44,000
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(567,831
|
)
|
(567,831
|
)
|
|||||||||||||
Balance - June 30, 2018
|
3,341,143
|
$
|
1,103
|
$
|
18,599,631
|
$
|
(19,408,341
|
)
|
$
|
(807,607
|
)
|
Common Stock
|
Additional
|
Accumulated
|
Total
|
|||||||||||||||||
|
Shares Issued
|
Amount
|
Paid-in Capital
|
Deficit
|
Equity (Deficit)
|
|||||||||||||||
Balance - March 31, 2019
|
5,172,938
|
$
|
1,707
|
$
|
38,642,411
|
$
|
(14,196,475
|
)
|
$
|
24,447,643
|
||||||||||
Stock-based compensation expense
|
–
|
–
|
18,580
|
–
|
18,580
|
|||||||||||||||
Issuance of common stock from 401K match
|
4,549
|
2
|
25,242
|
–
|
25,244
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(3,885,852
|
)
|
(3,885,852
|
)
|
|||||||||||||
Balance - June 30, 2019
|
5,177,487
|
$
|
1,709
|
$
|
38,686,233
|
$
|
(18,082,327
|
)
|
$
|
20,605,615
|
Common Stock
|
Additional
|
Accumulated
|
Total
|
|||||||||||||||||
|
Shares Issued
|
Amount
|
Paid-in Capital
|
Deficit
|
Equity (Deficit)
|
|||||||||||||||
Balance - December 31, 2017
|
3,051,538
|
$
|
1,007
|
$
|
17,492,083
|
$
|
(18,102,618
|
)
|
$
|
(609,528
|
)
|
|||||||||
Stock-based compensation expense
|
–
|
–
|
7,645
|
–
|
7,645
|
|||||||||||||||
Capitalized offering costs
|
–
|
–
|
(44,000
|
)
|
–
|
(44,000
|
)
|
|||||||||||||
Issuance of common stock, net of issuance costs
|
289,605
|
96
|
801,798
|
–
|
801,894
|
|||||||||||||||
Warrant costs associated with stock issuance
|
–
|
–
|
342,105
|
–
|
342,105
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(1,305,723
|
)
|
(1,305,723
|
)
|
|||||||||||||
Balance - June 30, 2018
|
3,341,143
|
$
|
1,103
|
$
|
18,599,631
|
$
|
(19,408,341
|
)
|
$
|
(807,607
|
)
|
Common Stock
|
Additional
|
Accumulated
|
Total
|
|||||||||||||||||
|
Shares Issued
|
Amount
|
Paid-in Capital
|
Deficit
|
Equity (Deficit)
|
|||||||||||||||
Balance - December 31, 2018
|
3,417,187
|
$
|
1,128
|
$
|
19,311,529
|
$
|
(21,013,174
|
)
|
$
|
(1,700,517
|
)
|
|||||||||
Stock-based compensation expense
|
–
|
–
|
2,773,451
|
–
|
2,773,451
|
|||||||||||||||
Issuance of common stock, net of issuance costs
|
48,930
|
16
|
749,984
|
–
|
750,000
|
|||||||||||||||
Issuance of common stock for antidilution
|
97,960
|
32
|
(32
|
)
|
–
|
–
|
||||||||||||||
Issuance of common stock for convertible debt
|
9,683
|
3
|
32,950
|
–
|
32,953
|
|||||||||||||||
Issuance of common stock from 401K match
|
4,549
|
2
|
25,241
|
–
|
25,243
|
|||||||||||||||
Equity from merger transaction
|
1,599,178
|
528
|
15,793,110
|
–
|
15,793,638
|
|||||||||||||||
Net income
|
–
|
–
|
–
|
2,930,847
|
2,930,847
|
|||||||||||||||
Balance - June 30, 2019
|
5,177,487
|
$
|
1,709
|
$
|
38,686,233
|
$
|
(18,082,327
|
)
|
$
|
20,605,615
|
Six Months Ended June 30,
|
||||||||
2019
|
2018
|
|||||||
Cash flows from operating activities:
|
||||||||
Net income (loss)
|
$
|
2,930,847
|
$
|
(1,305,723
|
)
|
|||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
2,773,451
|
51,642
|
||||||
Stock-based 401K company common match
|
25,244
|
–
|
||||||
Depreciation expense
|
62,706
|
14,297
|
||||||
Bargain purchase gain
|
(11,939,331
|
)
|
–
|
|||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
157,273
|
20,210
|
||||||
Accounts payable
|
(1,157,171
|
)
|
171,960
|
|||||
Accrued expenses
|
(292,678
|
)
|
227,911
|
|||||
Restructuring reserve
|
(786,396
|
)
|
–
|
|||||
Net cash used in operating activities
|
(8,226,055
|
)
|
(819,703
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Cash received in reverse merger transaction
|
29,106,512
|
–
|
||||||
Net cash used in investing activities
|
29,106,512
|
–
|
||||||
Cash flows from financing activities:
|
||||||||
Payments for capital lease obligation
|
–
|
(7,022
|
)
|
|||||
Proceeds from issuance of common stock, net of issuance costs
|
750,000
|
1,056,002
|
||||||
Net cash provided by financing activities
|
750,000
|
1,048,980
|
||||||
Net increase in cash
|
21,630,457
|
229,277
|
||||||
Cash and cash equivalents at beginning of period
|
103,695
|
175,884
|
||||||
Cash and cash equivalents at end of period
|
$
|
21,734,152
|
$
|
405,161
|
||||
Supplemental disclosure of cash flow information:
|
||||||||
Cash paid for:
|
||||||||
Interest
|
$
|
606
|
$
|
1,753
|
||||
Supplemental cash flow information:
|
||||||||
Conversion of convertible notes and accrued interest into common stock
|
$
|
32,953
|
$
|
–
|
||||
Consideration in connection with reverse merger transaction
|
$
|
15,793,638
|
$
|
–
|
(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:
|
(H) |
Stock-based compensation:
|
|
As of June 30,
|
|||||||
|
2019
|
2018
|
||||||
Stock options to purchase Common Stock
|
1,418,301
|
513,534
|
||||||
Convertible promissory note
|
–
|
9,216
|
||||||
Warrants to purchase Common Stock
|
262,758
|
115,860
|
||||||
Total
|
1,681,059
|
638,610
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Numerator
|
||||||||||||||||
Basic and diluted net income (loss)
|
$
|
(3,885,852
|
)
|
$
|
(567,831
|
)
|
$
|
2,930,847
|
$
|
(1,305,723
|
)
|
|||||
Denominator
|
||||||||||||||||
Shares used in computing basic net income (loss) per share
|
5,175,837
|
3,338,214
|
4,466,025
|
3,170,804
|
||||||||||||
Shares from dilutive securities
|
–
|
–
|
1,211,335
|
–
|
||||||||||||
Shares used in computing diluted net income (loss) per share
|
5,175,837
|
3,338,214
|
5,677,360
|
3,170,804
|
||||||||||||
|
||||||||||||||||
Net income (loss) per share, basic
|
(0.75
|
)
|
(0.17
|
)
|
0.66
|
(0.41
|
)
|
|||||||||
Net income (loss) per share, diluted
|
(0.75
|
)
|
(0.17
|
)
|
0.52
|
(0.41
|
)
|
(K) |
Accounting standards not yet adopted:
|
Number of shares of the combined company to be owned by Edge security holders (1)
|
1,600,166
|
|||
Multiplied by the price per share of Edge’s common stock as of March 15, 2019
|
$
|
9.87
|
||
Purchase price (in thousands)
|
$
|
15,794
|
(1) |
The amount includes 1,576,916 shares of Edge’s common stock outstanding as of March 15, 2019 plus 23,250 stock options of Edge that were in the money and vested immediately upon closing of the Merger. At closing, 753 of in-the-money
options and 235 fractional shares paid out in cash to shareholders were not issued as common stock, resulting in 1,599,178 common shares issued.
|
Cash and cash equivalents
|
$
|
29,106,513
|
||
Prepaid expense and other assets (1)
|
1,716,732
|
|||
Right to use asset
|
1,384,810
|
|||
Intangible assets-IPR&D
|
1,223,000
|
|||
Total identifiable assets acquired
|
33,431,055
|
|||
Accounts payable, accrued expenses, other liabilities
|
(4,595,934
|
)
|
||
Lease liability
|
(945,152
|
)
|
||
Deferred tax liability
|
(157,000
|
)
|
||
Total liabilities assumed
|
(5,698,086
|
)
|
||
Net identifiable assets acquired
|
27,732,969
|
|||
Bargain purchase gain
|
(11,939,331
|
)
|
||
Purchase price
|
$
|
15,793,638
|
(1) |
The valuation of equipment held for sale was believed to be $0 at the date of acquisition based on recent sales interest. Subsequent to the acquisition date, there was an offer on the equipment for a price of $275,000, as such the
Company deemed this would have been the value of the equipment if this sales offer would been available at the date of acquisition.
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Pro forma operating expenses
|
$
|
14,388,478
|
$
|
13,072,199
|
$
|
19,324,357
|
$
|
33,905,229
|
||||||||
Pro forma net loss
|
(14,686,971
|
)
|
(13,245,463
|
)
|
(19,809,603
|
)
|
(34,823,458
|
)
|
||||||||
Pro forma basic and diluted net loss per share
|
$
|
(2.84
|
)
|
$
|
(2.70
|
)
|
$
|
(4.44
|
)
|
$
|
(7.37
|
)
|
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 June 30, 2019: (unaudited)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
21,734,152
|
$
|
21,734,152
|
$
|
–
|
$
|
–
|
||||||||
As of December 31, 2018:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
103,695
|
$
|
103,695
|
$
|
–
|
$
|
–
|
Reported as of June 30, 2019
|
||||
Current portion of operating lease liability
|
$
|
492,086
|
||
Operating leases, net of current portion
|
774,278
|
|||
Total
|
$
|
1,266,364
|
As of
June 30, 2019
|
As of
December 31, 2018
|
|||||||
Accrued research and development costs
|
$
|
91,229
|
$
|
71,329
|
||||
Accrued professional fees
|
242,732
|
421,617
|
||||||
Accrued compensation
|
304,225
|
54,269
|
||||||
Accrued other
|
–
|
46,674
|
||||||
Accrued rent
|
–
|
8,000
|
||||||
Total
|
$
|
638,186
|
$
|
601,889
|
As of
June 30, 2019
|
As of
December 31, 2018
|
|||||||
Restructuring reserve (1)
|
$
|
1,283,875
|
$
|
–
|
||||
Total
|
$
|
1,283,875
|
$
|
–
|
(1) |
Restructuring reserve relates to the severance costs incurred by Edge Therapeutics prior to the merger transaction and assumed by the Company as part of the purchase accounting, but not yet paid. The severance costs continue through
September 2020. For the six months ended June 30, 2019, the Company paid $786,396 of restructuring expense which was previously recorded on Edge Therapeutics financials.
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
|
(unaudited)
|
(unaudited)
|
||||||||||||||
Stock-Based Compensation
|
||||||||||||||||
Research and development
|
$
|
9,387
|
$
|
43,997
|
$
|
450,087
|
$
|
47,216
|
||||||||
General and administrative
|
9,193
|
630
|
2,323,364
|
4,426
|
||||||||||||
Total
|
$
|
18,580
|
$
|
44,627
|
$
|
2,773,451
|
$
|
51,642
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
|
Weighted Average
|
Weighted Average
|
Weighted Average
|
Weighted Average
|
||||||||||||
|
(unaudited)
|
(unaudited)
|
||||||||||||||
Volatility
|
94.43
|
%
|
0.00
|
%
|
88.87
|
%
|
0.00
|
%
|
||||||||
Risk-Free Interest Rate
|
2.19
|
%
|
0.00
|
%
|
2.34
|
%
|
0.00
|
%
|
||||||||
Expected Term in Years
|
6.08
|
–
|
6.17
|
–
|
||||||||||||
Dividend Rate
|
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
0.00
|
%
|
||||||||
Fair Value of Option on Grant Date
|
$
|
4.77
|
$
|
–
|
$
|
5.31
|
$
|
–
|
Number
of Shares
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining Contractual
Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at December 31, 2018
|
541,117
|
$
|
7.20
|
|||||||||||||
Assumed in connection with Merger
|
347,697
|
121.52
|
||||||||||||||
Granted
|
800,137
|
7.57
|
||||||||||||||
Exercised
|
–
|
–
|
||||||||||||||
Forfeited
|
(270,650
|
)
|
99.13
|
|||||||||||||
Options outstanding at June 30, 2019
|
1,418,301
|
$
|
17.90
|
7.49
|
$
|
24,059
|
||||||||||
Vested and expected to vest at June 30, 2019
|
1,418,301
|
$
|
17.90
|
7.49
|
$
|
24,059
|
||||||||||
Exercisable at June 30, 2019
|
1,007,871
|
$
|
22.67
|
6.47
|
$
|
24,059
|
● |
the accuracy of estimates of our expenses, future revenue, capital requirements and our needs for additional financing;
|
● |
our ability to obtain funding for our operations in the event we determine to raise additional capital;
|
● |
our ability to retain key management personnel;
|
● |
the accuracy of our estimates regarding expenses, future revenues and capital requirements;
|
● |
our ability to maintain our listing on the Nasdaq Stock Market;
|
● |
regulatory developments in the United States and foreign countries;
|
● |
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”); and
|
● |
other risks and uncertainties, including those listed under Part II, Item 1A. Risk Factors.
|
● |
the timing and costs of our planned clinical trials;
|
● |
the timing and costs of our planned preclinical studies of its Versamune® platform;
|
● |
the outcome, timing and costs of seeking regulatory approvals;
|
● |
the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;
|
● |
the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights;
and
|
● |
the extent to which we in-licenses or acquires other products and technologies.
|
Three Months Ended June 30,
|
Increase (Decrease)
|
|||||||||||||||
2019
|
2018
|
$
|
|
%
|
||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
1,887
|
$
|
169
|
$
|
1,718
|
1,017
|
%
|
||||||||
General and administrative expenses
|
2,384
|
398
|
1,986
|
499
|
%
|
|||||||||||
Total operating expenses
|
4,271
|
567
|
3,704
|
653
|
%
|
|||||||||||
Loss from operations
|
(4,271
|
)
|
(567
|
)
|
(3,704
|
)
|
653
|
%
|
||||||||
Other income (expense), net
|
209
|
–
|
209
|
100
|
%
|
|||||||||||
Interest income (expense), net
|
176
|
(1
|
)
|
177
|
100
|
%
|
||||||||||
Net loss and comprehensive loss
|
$
|
(3,886
|
)
|
$
|
(568
|
)
|
$
|
(3,318
|
)
|
584
|
%
|
|
Six Months Ended June 30,
|
Increase (Decrease)
|
||||||||||||||
|
2019
|
2018
|
$
|
|
%
|
|||||||||||
|
(in thousands)
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
2,917
|
$
|
370
|
$
|
2,547
|
688
|
%
|
||||||||
General and administrative expenses
|
6,290
|
934
|
5,356
|
573
|
%
|
|||||||||||
Total operating expenses
|
9,207
|
1,304
|
7,903
|
606
|
%
|
|||||||||||
Loss from operations
|
(9,207
|
)
|
(1,304
|
)
|
(7,903
|
)
|
606
|
%
|
||||||||
Other income (expense), net
|
11,939
|
–
|
11,939
|
11,939
|
||||||||||||
Interest (expense), net
|
199
|
(2
|
)
|
201
|
100
|
%
|
||||||||||
Net loss and comprehensive loss
|
$
|
2,931
|
$
|
(1,306
|
)
|
$
|
4,237
|
(324
|
)%
|
Six Months Ended June 30,
|
||||||||
2019
|
2018
|
|||||||
Net cash used in operating activities
|
$
|
(8,226
|
)
|
$
|
(820
|
)
|
||
Net cash provided by investing activities
|
29,106
|
–
|
||||||
Net cash provided by financing activities
|
750
|
1,049
|
||||||
Net increase in cash
|
$
|
21,630
|
$
|
229
|
● |
the initiation, progress, timing, costs and results of our planned clinical trials;
|
● |
the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory authorities;
|
● |
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
● |
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;
|
● |
the effect of competing technological and market developments;
|
● |
the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our tablet vaccines on our own; and
|
● |
the initiation, progress, timing and results of our commercialization of our tablet vaccine candidates, if approved, for commercial sale.
|
As of June 30, 2019
|
Total
|
Less than
one year
|
1-3 Years
|
3-5 Years
|
More than
5 Years
|
|||||||||||||||
(in thousands)
|
||||||||||||||||||||
Operating lease obligations
|
$
|
1,433
|
$
|
600
|
$
|
833
|
$
|
–
|
$
|
–
|
||||||||||
Milestone payments
|
550
|
110
|
220
|
220
|
–
|
|||||||||||||||
Total contractual obligations
|
$
|
1,983
|
$
|
710
|
$
|
1,053
|
$
|
220
|
$
|
–
|
Exhibit
Number
|
Exhibit Description
|
|
10.1
|
Employment Agreement, dated October 11, 2018, by and between PDS Biotechnology Corporation and Frank K.
Bedu-Addo
(filed as Exhibit 10.19 to the Company’s Registration Statement on Form S-4 (File No. 333-228937) on December 21, 2018, and incorporated by reference herein).
|
|
10.2
|
Consulting Services Agreement, dated December 15, 2014, by and between PDS Biotechnology Corporation and Gregory
Freitag
(filed as Exhibit 10.20 to the Company’s Registration Statement on Form S-4 (File No. 333-228937) on December 21, 2018, and incorporated by reference herein).
|
|
10.3
|
Consulting Services Agreement, dated December 15, 2014, by and between PDS Biotechnology Corporation and DeLyle
Bloomquist
(filed as Exhibit 10.21 to the Company’s Registration Statement on Form S-4 (File No. 333-228937) on December 21, 2018, and incorporated by reference herein).
|
|
10.4
|
Offer Letter, dated September 21, 2018, by and between PDS Biotechnology Corporation and Lauren Wood, MD
.
(filed as Exhibit 10.22 to the Company’s Registration Statement on Form S-4 (File No. 333-228937) on December 21, 2018, and incorporated by reference herein).
|
|
10.5
|
Consulting Services Agreement, dated March 26, 2015, by and between PDS Biotechnology Corporation and Gregory
Conn
(filed as Exhibit 10.23 to the Company’s Registration Statement on Form S-4 (File No. 333-228937) on December 21, 2018, and incorporated by reference herein).
|
|
10.6
|
Clinical Trial Collaboration and Supply Agreement, dated May 19, 2017, by and between PDS Biotechnology
Corporation and MSD International GmbH
(filed as Exhibit 10.24 to the Company’s Registration Statement on Form S-4/A (File No. 333-228937) on January 25, 2019, and incorporated by reference herein).
|
|
10.7
|
Patent License Agreement, dated January 5, 2015, by and between PDS Biotechnology Corporation and National
Institutes of Health, as amended by First Amendment, dated August 5, 2015
(filed as Exhibit 10.25 to the Company’s Registration Statement on Form S-4/A (File No. 333-228937) on January 25, 2019, and incorporated by reference herein).
|
|
10.8
|
Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and
University of Kentucky Research Foundation
(filed as Exhibit 10.26 to the Company’s Registration Statement on Form S-4/A (File No. 333-228937) on January 25, 2019, and incorporated by reference herein).
|
|
10.9
|
Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and
University of Kentucky Research Foundation
(filed as Exhibit 10.27 to the Company’s Registration Statement on Form S-4/A (File No. 333-228937) on January 25, 2019, and incorporated by reference herein).
|
|
10.10
|
Public Health Service Cooperative Research & Development Agreement for Intramural-PHS Clinical Research,
dated effective as of February 2, 2015, by and between the National Cancer Institute and PDS Biotechnology Corporation
(filed as Exhibit 10.28 to the Company’s Registration Statement on Form S-4/A (File No. 333-228937) on January 25,
2019, and incorporated by reference herein).
|
|
10.11
|
DOTAP Chloride Enantiomer License Agreement effective November 1, 2008, between Merck Eprova AG and PDS
Biotechnology Corporation
(filed as Exhibit 10.29 to the Company’s Registration Statement on Form S-4/A (File No. 333-228937) on January 25, 2019, and incorporated by reference herein).
|
|
Employment Agreement, effective June 1, 2019, by and between PDS Biotechnology Corporation and Gregory Conn.
|
||
10.13
|
Offer Letter, dated February 1, 2019, by and between PDS Biotechnology Corporation and Lauren V. Wood, M.D.
|
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith).
|
||
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith).
|
||
32.1
*
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
|
32.2
*
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
|
|
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
|
* |
The certifications furnished in Exhibit 32.1 and Exhibit 32.2 hereto are deemed to accompany this Quarterly Report and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to
the extent that the Company specifically incorporates it by reference.
|
PDS Biotechnology Corporation
|
||
August 1, 2019
|
By:
|
/s/ Frank Bedu-Addo
|
Frank Bedu-Addo
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
||
August 1, 2019
|
By:
|
/s/ Andrew Saik
|
Andrew Saik
|
||
Chief Financial Officer
|
||
(Principal Financial and Accounting Officer)
|
I.
|
POSITION
|
II.
|
COMPENSATION
|
A.
|
Base Salary
|
B.
|
Performance-Based Annual Bonus.
|
C.
|
Equity Awards
|
D.
|
Benefits
|
E.
|
Cause; Termination by Executive Without Good Reason
|
F.
|
Delay of Certain Termination Payments.
|
III.
|
RESTRICTIVE COVENANTS
|
A.
|
Acknowledgements
|
B.
|
Restrictive Covenants
|
a.
|
solicit or recruit the employment or services of any person, whether as an employee, officer, director, agent, consultant or independent contractor, who is, or was within 12 months preceding the date of solicitation or hiring (as
applicable), an employee or service provider of the Company, or knowingly induce or knowingly attempt to induce any such employee or service provider to terminate his or her employment or service, as applicable, or breach his or her
employment or service agreement, as applicable, if any, with the Company; or
|
b.
|
encourage any such individual to change such individual
’
s relationship with the Company in a manner adverse to the Company.
|
C.
|
Injunctive Relief
|
D.
|
Conflicting Agreements
|
E.
|
Separate Covenants.
|
IV.
|
DEFINITIONS
|
V.
|
MISCELLANEOUS
|
A.
|
Section 409A
|
B.
|
Other Employment Matters
|
C.
|
Arbitration
|
D.
|
Entire Agreement; Modification; Governing Law
|
E.
|
Severability
|
F.
|
Counterparts
|
G.
|
Headings and Construction
|
H.
|
Successors and Assigns
|
I.
|
Attorney Fees
|
COMPANY
|
|||||
By:
|
/s/ Frank Bedu-Addo
|
Date: |
|
6/25/19
|
|
Name: Frank Bedu-Addo
|
|||||
Title: Chief Executive Officer
|
|||||
EXECUTIVE
|
|||||
Date: |
|
6/25/19
|
|||
/s/ Gregory Conn
|
|||||
Name: Gregory Conn
|
|
(a) |
Base Salary
. Upon full-time employment at the Company following the successful closing of the impending corporate financing, you will be paid an annual base salary. Your annual
base salary if the company remains privately held will be two-hundred and ninety thousand dollars ($290,000 US), payable in accordance with the Company’s customary payroll practices. If the company becomes listed on a United States stock
exchange your annual base salary will be three-hundred and twenty thousand dollars ($320,000 US), payable in accordance with the Company’s customary payroll practices. Your base salary for the year ending December 31, 2019 shall be
prorated based upon your time as a full-time employee. Your salary will be subject to an annual review by the CEO and the board of directors of the Company (the “Board”) in accordance with the Company’s compensation policies. Naturally,
your compensation, including base salary and any bonus earned, is contingent upon your continued employment with the Company and will be paid as earned in accordance with Company policy and procedures.
|
|
(b) |
Annual Bonus
. For the year beginning January 1, 2019, and for each full year of full-time employment with the Company that begins thereafter, you are eligible to receive a
discretionary annual bonus, as determined by the Board in its sole discretion based on the performance of the Company for the year, and provided you are employed by the Company on the bonus payment date. You will be eligible to earn an
annual bonus up to thirty percent (30%) of your annual base salary for the year, based on criteria determined between you and the CEO. Any annual bonus earned for a fiscal year shall be paid following the end of the fiscal year (which
runs from January through December) and no later than March 15 of such following year.
|
|
(c) |
Compensatory Equity Grant
.
|
|
(i) |
Upon your conversion to full-time employment following the successful closing of the impending corporate financing, you will receive options for the purchase of one hundred and ninety-two
thousand, two hundred and sixty-eight (192,268) shares of the Company’s common stock, which represents approximately one and a half percent (1.5%) of the outstanding shares of the Company’s common stock, on a fully-diluted basis, as of
the date of this offer. Any option grants made to you shall vest as described in Section 1(c)(ii) below. The exercise price per share of common stock shall be based on the fair market value of common stock as of the date of each grant,
as determined by the Board in its sole discretion.
|
|
(ii) |
Any option grant to you shall vest over a three (3) year period, with one thirty-sixth (1/36th) of such grant vesting on each month following such grant, subject in each case to your
continued employment with the Company. All option grants shall be granted under, and in accordance with the terms of, the Company’s equity compensation plan. All option grants pursuant to this offer letter shall be memorialized through
a grant agreement containing such customary terms as are determined by the Board in its sole discretion. Nothing in this offer letter precludes the Company from amending or terminating any equity compensation plan or program after the
date hereof.
|
|
(iii) |
All option grants made to you may be subject to customary redemption, right of first refusal, and tag/drag rights, as determined by the Board in its sole discretion.
|
|
(iv) |
The vesting of any grants made pursuant to this offer letter shall accelerate in the event of a change in control of the Company. The definition of change in control shall be a customary
definition determined by the Board in its sole discretion, and shall not, for example, include transactions such as an IPO or a financing.
|
|
(a) |
This offer is contingent upon your execution of our standard Proprietary Information, Inventions, Non-Competition and Non-Solicitation Agreement, which is attached hereto as Exhibit A.
|
|
(b) |
Your employment with the Company is subject to your providing proof of your eligibility to work in the United States. If we do not already have it, you must supply us with a completed
Employment Verification Form (1-9 attached) with required original (photocopies cannot be accepted) supporting documents, including a social security card and a driver’s license, birth certificate or U.S. Passport.
|
|
(c) |
If we do not already have the form in our file, you will be required to complete and return a W-9 federal tax withholding form so that we can process your first pay period. In preparing
your W-9, remember to write your name exactly as it appears on your social security card or work visa.
|
|
(d) |
Although we sincerely hope that your employment with the Company will be mutually satisfying, your employment with the Company is at-will. This means that your employment with the Company
can be terminated by the Company for any reason, with or without cause, and without prior notice. This also means that you may terminate your employment with the Company at any time upon proper notice (at least 2 weeks). Although the
Company has no present intention to do so, it necessarily reserves the right to terminate, amend or modify all human resources policies and benefits programs described herein without notice.
|
|
(e) |
While you are employed by the Company, you will be expected to devote your full working time, energy, skill and experience to the performance of your duties, which may be redefined or
modified by the Company from time to time.
|
|
(f) |
Without the express consent of the Board, you shall have no apparent or implied authority to pledge the credit of the Company, to bind the Company under any contract, note, mortgage or
other agreement outside the ordinary course of Company’s business, to release or discharge any debt due the Company, or to sell, mortgage, transfer or otherwise dispose of any assets of the Company.
|
|
(g) |
This letter agreement will be governed by the laws of the State of Delaware.
|
/s/ Lauren V. Wood
(signature)
Dated:
February 8, 2019
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of PDS Biotechnology Corporation for the period ended June 30, 2019;
|
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 condensed consolidated 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 condensed consolidated 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: August 1, 2019
|
/s/ Frank Bedu-Addo
|
|
Frank Bedu-Addo
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of PDS Biotechnology Corporation for the period ended June 30, 2019;
|
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 condensed consolidated 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 condensed consolidated 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: August 1, 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: August 1, 2019
|
/s/ Frank Bedu-Addo
|
|
Frank Bedu-Addo
|
|
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: August 1, 2019
|
/s/ Andrew Saik
|
|
Andrew Saik
|
|
Chief Financial Officer
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(Principal Financial Officer)
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