☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT PURSUANT TO 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.)
|
25B Vreeland Road, Suite 300, Florham Park, NJ 07932
|
||
(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)
|
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
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
Non-accelerated filer ☒
|
Smaller Reporting Company ☒
|
Emerging growth company ☐
|
Page
|
|||
Part I — Financial Information
|
|||
Item 1.
|
Financial Statements (Unaudited):
|
||
1
|
|||
2
|
|||
3
|
|||
4
|
|||
5
|
|||
Item 2.
|
13
|
||
Item 3.
|
23
|
||
Item 4.
|
23
|
||
Part II — Other Information
|
|
||
Item 1.
|
24
|
||
Item 1A.
|
24
|
||
Item 2.
|
24
|
||
Item 3.
|
24
|
||
Item 4.
|
24
|
||
Item 5.
|
24
|
||
Item 6.
|
24
|
||
25
|
|||
26
|
PART 1.
|
FINANCIAL INFORMATION
|
ITEM 1.
|
FINANCIAL STATEMENTS
|
Three Months Ended March 31,
|
||||||||
2021
|
2020
|
|||||||
Operating expenses:
|
||||||||
Research and development expenses
|
$
|
1,413,057
|
$
|
1,971,679
|
||||
General and administrative expenses
|
1,636,216
|
2,060,148
|
||||||
Total operating expenses
|
3,049,273
|
4,031,827
|
||||||
Loss from operations
|
(3,049,273
|
)
|
(4,031,827
|
)
|
||||
Other income
|
||||||||
Interest income
|
655
|
46,419
|
||||||
Net loss and comprehensive loss
|
$
|
(3,048,618
|
)
|
$
|
(3,985,408
|
)
|
||
Per share information:
|
||||||||
Net loss per share, basic
|
$
|
(0.14
|
)
|
$
|
(0.39
|
)
|
||
Net loss per share, diluted
|
$
|
(0.14
|
)
|
$
|
(0.39
|
)
|
||
Weighted average common shares outstanding, basic
|
22,263,838
|
10,314,761
|
||||||
Weighted average common shares outstanding, diluted
|
22,263,838
|
10,314,761
|
Common Stock
|
Additional
Paid-in
Capital
|
|
||||||||||||||||||
Shares
Issued
|
Amount
|
Accumulated
Deficit
|
Total Equity
|
|||||||||||||||||
Balance - December 31, 2019
|
5,281,237
|
$
|
1,742
|
$
|
40,633,670
|
$
|
(28,937,705
|
)
|
$
|
11,697,707
|
||||||||||
Stock based compensation expense
|
–
|
–
|
124,992
|
–
|
124,992
|
|||||||||||||||
Issuance of common stock, net of issuance costs
|
10,000,000
|
3,299
|
11,966,703
|
–
|
11,970,002
|
|||||||||||||||
Issuance of common stock for warrant exercise
|
65,240
|
22
|
70,437
|
–
|
70,459
|
|||||||||||||||
Issuance of common stock from 401K match
|
3,968
|
1
|
9,799
|
–
|
9,800
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(3,985,408
|
)
|
(3,985,408
|
)
|
|||||||||||||
Balance - March 31, 2020
|
15,350,445
|
$
|
5,064
|
$
|
52,805,601
|
$
|
(32,923,113
|
)
|
$
|
19,887,552
|
Common Stock
|
Additional
Paid-in
Capital
|
|
||||||||||||||||||
Shares
Issued
|
Amount
|
Accumulated
Deficit
|
Total Equity
|
|||||||||||||||||
Balance - December 31, 2020
|
22,261,619
|
$
|
7,346
|
$
|
70,907,315
|
$
|
(43,785,085
|
)
|
$
|
27,129,576
|
||||||||||
Stock-based compensation expense
|
–
|
–
|
257,622
|
–
|
257,622
|
|||||||||||||||
Issuance of common stock from 401K match
|
16,642
|
–
|
35,747
|
–
|
35,747
|
|||||||||||||||
Net loss
|
–
|
–
|
–
|
(3,048,618
|
)
|
(3,048,618
|
)
|
|||||||||||||
Balance - March 31, 2021
|
22,278,261
|
$
|
7,346
|
$
|
71,200,684
|
$
|
(46,833,703
|
)
|
$
|
24,374,327
|
Three Months Ended March 31,
|
||||||||
2021
|
2020
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(3,048,618
|
)
|
$
|
(3,985,408
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
257,622
|
124,992
|
||||||
Stock-based 401K company common match
|
35,747
|
9,800
|
||||||
Depreciation expense
|
1,860
|
3,902
|
||||||
Operating lease expense
|
60,257
|
-
|
||||||
Changes in assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(721,849
|
)
|
(570,916
|
)
|
||||
Accounts payable
|
(464,626
|
)
|
1,358,983
|
|||||
Accrued expenses
|
119,473
|
122,551
|
||||||
Restructuring reserve
|
-
|
(228,298
|
)
|
|||||
Operating lease liabilities
|
(42,057
|
)
|
-
|
|||||
Net cash used in operating activities
|
(3,802,191
|
)
|
(3,164,394
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from exercise of warrants
|
–
|
70,459
|
||||||
Proceeds from issuance of common stock, net of issuance costs
|
–
|
11,970,002
|
||||||
Net cash provided by financing activities
|
12,040,461
|
|||||||
Net increase (decrease) in cash and cash equivalents
|
(3,802,191
|
)
|
8,876,067
|
|||||
Cash and cash equivalents at beginning of period
|
28,839,565
|
12,161,739
|
||||||
Cash and cash equivalents at end of period
|
$
|
25,037,374
|
$
|
21,037,806
|
(A) |
Unaudited interim financial statements:
|
(B) |
Use of estimates:
|
(C) |
Significant risks and uncertainties:
|
(D) |
Cash equivalents and concentration of cash balance:
|
(E) |
Research and development:
|
(F) |
Patent costs:
|
(G) |
Stock-based compensation:
|
(H) |
Net income (loss) per common share:
|
|
As of March 31,
|
|||||||
2021
|
2020
|
|||||||
Stock options to purchase Common Stock
|
1,899,193
|
1,413,073
|
||||||
Warrants to purchase Common Stock
|
197,518
|
197,518
|
||||||
Total
|
2,096,711
|
1,610,591
|
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 March 31, 2021: (unaudited)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
25,037,374
|
$
|
25,037,374
|
$
|
–
|
$
|
–
|
||||||||
As of December 31, 2020
|
||||||||||||||||
Cash and cash equivalents
|
$
|
28,839,565
|
$
|
28,839,565
|
$
|
–
|
$
|
–
|
As of March 31,
|
||||||||
2021
|
2020
|
|||||||
Cash paid for operating lease liabilities
|
$
|
42,057
|
$
|
-
|
||||
Right-of use assets recorded in exchange for lease obligations
|
$
|
-
|
$
|
-
|
Year ended December 31,
|
||||
2021 (remaining nine months)
|
$
|
128,779
|
||
2022
|
295,346
|
|||
2023
|
239,469
|
|||
2024
|
-
|
|||
2025 and after
|
-
|
|||
Total future minimum lease payments
|
663,594
|
|||
Less inputed interest
|
(81,649
|
)
|
||
$
|
581,945
|
As of
March 31, 2021
|
As of
December 31, 2020
|
|||||||
Accrued research and development costs
|
$
|
23,900
|
$
|
204,780
|
||||
Accrued professional fees
|
320,266
|
219,822
|
||||||
Accrued compensation
|
1,510,629
|
1,310,720
|
||||||
Total
|
$
|
1,854,795
|
$
|
1,735,322
|
Three Months Ended March 31,
|
||||||||
2021
|
2020
|
|||||||
(unaudited)
|
||||||||
Stock-Based Compensation
|
||||||||
Research and development
|
$
|
60,385
|
$
|
52,684
|
||||
General and administrative
|
197,236
|
72,308
|
||||||
Total
|
$
|
257,622
|
$
|
124,992
|
Three Months Ended March 31,
|
||||||||
2021
|
2020
|
|||||||
Weighted Average
|
Weighted Average
|
|||||||
(unaudited)
|
||||||||
Volatility
|
100.38
|
%
|
92.56
|
%
|
||||
Risk-Free Interest Rate
|
0.35
|
%
|
1.56
|
%
|
||||
Expected Term in Years
|
5.82
|
6.01
|
||||||
Dividend Rate
|
0.00
|
%
|
0.00
|
%
|
||||
Fair Value of Option on Grant Date
|
$
|
1.73
|
$
|
0.99
|
Number
of Shares
|
Weighted
Average
Exercise Price
|
Weighted Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at December 31, 2020
|
1,650,897
|
$
|
11.87
|
|||||||||||||
Granted
|
267,800
|
2.32
|
||||||||||||||
Exercised
|
–
|
–
|
||||||||||||||
Forfeited
|
(19,500
|
)
|
23.87
|
|||||||||||||
Expired
|
–
|
–
|
||||||||||||||
Options outstanding at March 31, 2021
|
1,899,197
|
$
|
10.40
|
7.2
|
$
|
1,654,588
|
||||||||||
Vested and expected to vest at March 31, 2021
|
1,899,197
|
$
|
10.40
|
7.2
|
$
|
1,654,588
|
||||||||||
Exercisable at March 31, 2021
|
1,167,963
|
$
|
15.10
|
5.52
|
$
|
157,569
|
ITEM 2. |
|
● |
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 the need 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;
|
|
● |
unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19;
|
|
● |
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.
|
PDS0101 in Combination with KEYTRUDA® Clinical Trial:
|
Other Versamune® Products Under Development:
|
PDS0102 – Versamune® + TARP antigens
|
PDS0103 – Versamune® + MUC-1 antigens
|
PDS0104 – Versamune® + TRP-2 and melanoma antigens
|
|
● |
the timing and costs of our planned clinical trials;
|
|
● |
the timing and costs of our planned preclinical studies of our 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 license or acquire other products and technologies.
|
Three Months Ended
March 31,
|
Increase (Decrease)
|
|||||||||||||||
2021
|
2020
|
$ Amount
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
1,413
|
$
|
1,971
|
$
|
(559
|
)
|
(28
|
)%
|
|||||||
General and administrative expenses
|
1,636
|
2,060
|
(424
|
)
|
(21
|
)%
|
||||||||||
Total operating expenses
|
3,049
|
4,031
|
(983
|
)
|
(24
|
)%
|
||||||||||
Loss from operations
|
(3,049
|
)
|
(4,031
|
)
|
983
|
(24
|
)%
|
|||||||||
Interest income, net
|
1
|
46
|
(45
|
)
|
(98
|
)%
|
||||||||||
Net loss and comprehensive loss
|
$
|
(3,048
|
)
|
$
|
(3,985
|
)
|
$
|
936
|
(23
|
)%
|
Three Months Ended March 31,
|
||||||||
2021
|
2020
|
|||||||
Net cash used in operating activities
|
$
|
(3,802
|
)
|
$
|
(3,164
|
)
|
||
Net cash provided by financing activities
|
–
|
12,040
|
||||||
Net increase (decrease) in cash and cash equivalents
|
$
|
(3,802
|
)
|
$
|
8,876
|
|
● |
the initiation, progress, timing, costs and results of our planned clinical trials;
|
|
● |
the effects of health epidemics, pandemics, or outbreaks of infectious diseases, including the recent COVID-19 pandemic, on our business operations, financial condition, results of operations and cash flows;
|
|
● |
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 products on our own; and
|
|
● |
the initiation, progress, timing and results of our commercialization of our product candidates, if approved, for commercial sale.
|
As of March 31, 2021
|
Total
|
Less than One Year
|
1-3 Years
|
3-5 Years
|
More than 5 Years
|
|||||||||||||||
Operating lease obligations
|
$
|
581,945
|
$
|
123,654
|
$
|
458,291
|
$
|
–
|
$
|
–
|
||||||||||
Total contractual obligations
|
$
|
581,945
|
$
|
123,654
|
$
|
458,291
|
$
|
–
|
$
|
–
|
ITEM 3: |
ITEM 4: |
PART II. |
OTHER INFORMATION
|
ITEM 1. |
ITEM 1A. |
ITEM 2. |
ITEM 3. |
ITEM 4. |
ITEM 5. |
ITEM 6. |
Exhibit
Number
|
Exhibit Description
|
|
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.
|
||
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.
|
||
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).
|
||
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
|
PDS Biotechnology Corporation
|
||
May 13, 2021
|
By:
|
/s/ Frank Bedu-Addo
|
Frank Bedu-Addo
|
||
President and Chief Executive Officer
(Principal Executive Officer)
|
||
May 13, 2021
|
By:
|
/s/ Seth Van Voorhees
|
Seth Van Voorhees
|
||
Chief Financial Officer
|
||
(Principal Financial and Accounting Officer)
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of PDS Biotechnology Corporation for the period ended March 31, 2021;
|
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: May 13, 2021
|
/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 March 31, 2021;
|
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;
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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;
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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:
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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;
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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;
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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
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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
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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):
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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
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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.
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Dated: May 13, 2021
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/s/ Seth Van Voorhees
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Seth Van Voorhees
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||
Chief Financial Officer
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||
(Principal Financial and Accounting Officer)
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(1) |
the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2) |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Dated: May 13, 2021
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/s/ Frank Bedu-Addo
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Frank Bedu-Addo
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||
President and Chief Executive Officer
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(Principal Executive Officer)
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(1) |
the Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2) |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Dated: May 13, 2021
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/s/ Seth Van Voorhees
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Seth Van Voorhees
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||
Chief Financial Officer
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||
(Principal Financial and Accounting Officer)
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