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
|
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||
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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||
(Address of principal executive offices)
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(
|
||
(Registrant’s telephone number)
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(Former name, former address and former fiscal year, if changed since last report)
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Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
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||
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Large accelerated filer ☐
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Accelerated filer ☐
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|
Smaller Reporting Company
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Emerging growth company
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Page
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|||
Part I — Financial Information
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|||
Item 1.
|
Financial Statements (Unaudited):
|
||
3
|
|||
4
|
|||
5
|
|||
7
|
|||
8
|
|||
Item 2.
|
17
|
||
Item 3.
|
28
|
||
Item 4.
|
28
|
||
Part II — Other Information
|
|||
Item 1.
|
29
|
||
Item 1A.
|
29
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||
Item 2.
|
29 |
||
Item 3.
|
29
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||
Item 4.
|
29 | ||
Item 5.
|
29
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||
Item 6.
|
29
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||
30
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|||
31
|
PART 1.
|
FINANCIAL INFORMATION
|
ITEM 1.
|
FINANCIAL STATEMENTS
|
June 30, 2021
|
December 31, 2020
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Prepaid expenses and other
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Operating lease right-to-use asset
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
LIABILITIES
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Operating lease obligation-short term
|
|
|
||||||
Total current liabilities
|
|
|
||||||
Noncurrent liability:
|
||||||||
Operating lease obligation-long term
|
|
|
||||||
Total Liabilities
|
$
|
|
$
|
|
||||
STOCKHOLDERS’ EQUITY
|
||||||||
Common stock, $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ equity
|
|
|
||||||
Total liabilities and stockholders’ equity
|
$
|
|
$
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
General and administrative expenses
|
|
|
|
|
||||||||||||
Total operating expenses
|
|
|
|
|
|
|||||||||||
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Interest income
|
|
|
|
|
||||||||||||
Loss before income taxes
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Benefit for income taxes
|
|
|
|
|
||||||||||||
Net loss and comprehensive loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Per share information:
|
||||||||||||||||
Net loss per share, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
Common Stock
|
Additional
|
|
Total
|
|||||||||||||||||
Shares
Issued
|
Amount
|
Paid-in
Capital
|
Accumulated
Deficit
|
Equity
(Deficit)
|
||||||||||||||||
Balance - March 31, 2020
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock based compensation expense
|
–
|
|
|
|
|
|||||||||||||||
Issuance of common stock from 401K match
|
|
|
|
|
|
|||||||||||||||
Net loss
|
–
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance - June 30, 2020
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Common Stock
|
Additional
|
|
Total
|
|||||||||||||||||
Shares
Issued
|
Amount
|
Paid-in
Capital
|
Accumulated
Deficit
|
Equity
(Deficit)
|
||||||||||||||||
Balance - March 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock based compensation expense
|
–
|
|
|
|
|
|||||||||||||||
Issuance of common stock, from exercise of stock options
|
|
|
|
|
||||||||||||||||
Issuance of common stock, net of issuance costs
|
|
|
|
|
|
|||||||||||||||
Net loss
|
–
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance - June 30, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Common Stock
|
Additional
|
|
Total
|
|||||||||||||||||
Shares
Issued
|
Amount
|
Paid-in
Capital
|
Accumulated
Deficit
|
Equity
(Deficit)
|
||||||||||||||||
Balance - December 31, 2019
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock based compensation expense
|
–
|
|
|
|
|
|||||||||||||||
Issuance of common stock, net of issuance costs
|
|
|
|
|
|
|||||||||||||||
Issuance of warrant exercise
|
|
|
|
|
|
|||||||||||||||
Issuance of common stock from 401K match
|
|
|
|
|
|
|||||||||||||||
Net loss
|
–
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance - June 30, 2020
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Common Stock
|
Additional
|
|
Total
|
|||||||||||||||||
Shares
Issued
|
Amount
|
Paid-in
Capital
|
Accumulated
Deficit
|
Equity
(Deficit)
|
||||||||||||||||
Balance - December 31, 2020
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock based compensation expense
|
–
|
|
|
|
|
|||||||||||||||
Issuances of common stock, net of issuance costs
|
|
|
|
|
|
|||||||||||||||
Issuance of common stock, from exercise of stock options
|
|
|
|
|
|
|||||||||||||||
Issuance of common stock from 401K match
|
|
|
|
|
|
|||||||||||||||
Net loss
|
–
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance - June 30, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Six Months Ended June 30,
|
||||||||
2021
|
2020
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
|
|
||||||
Stock-based 401K company common match
|
|
|
||||||
Depreciation expense
|
|
|
||||||
Operating lease expense
|
|
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(
|
)
|
(
|
)
|
||||
Accounts payable
|
|
(
|
)
|
|||||
Accrued expenses
|
(
|
)
|
|
|||||
Restructuring reserve
|
|
(
|
)
|
|||||
Operating lease liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from exercise of warrants
|
|
|
||||||
Proceeds from exercise of stock options
|
||||||||
Proceeds from issuances of common stock, net of issuance costs
|
|
|
||||||
Net cash provided by financing activities
|
|
|||||||
Net increase in cash and cash equivalents
|
|
|
||||||
Cash and cash equivalents at beginning of period
|
|
|
||||||
Cash and cash equivalents at end of period
|
$
|
|
$
|
|
(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 June 30,
|
||||||||
2021
|
2020
|
|||||||
Stock options to purchase Common Stock
|
|
|
||||||
Warrants to purchase Common Stock
|
|
|
||||||
Total
|
|
|
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, 2021: (unaudited)
|
||||||||||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
As of December 31, 2020:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
$
|
|
$
|
|
As of June 30,
|
||||||||
2021
|
2020
|
|||||||
Cash paid for operating lease liabilities
|
$
|
|
$
|
|
||||
Right-of use assets recorded in exchange for lease obligations
|
$
|
|
$
|
|
Year ended December 31,
|
||||
2021 (remaining six months)
|
$
|
|
||
2022
|
|
|||
2023
|
|
|||
2024
|
|
|||
2025 and after
|
|
|||
Total future minimum lease payments
|
|
|||
Less imputed interest
|
(
|
)
|
||
$
|
|
As of
June 30, 2021
|
As of
December 31, 2020
|
|||||||
Accrued research and development costs
|
$
|
|
$
|
|
||||
Accrued professional fees
|
|
|
||||||
Accrued compensation
|
|
|
||||||
Total
|
$
|
|
$
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Stock-Based Compensation
|
||||||||||||||||
Research and development
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
General and administrative
|
|
(
|
)
|
|
|
|||||||||||
Total
|
$
|
|
$
|
|
$
|
|
$
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Weighted Average
|
Weighted Average
|
Weighted Average
|
Weighted Average
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Volatility
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Risk-Free Interest Rate
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Expected Term in Years
|
|
|
|
|
||||||||||||
Dividend Rate
|
|
|
|
|
||||||||||||
Fair Value of Option on Grant Date
|
$
|
|
$
|
|
$
|
|
$
|
|
Number
of Shares
|
Weighted
Average
Exercise Price
|
Weighted Average
Remaining
Contractual
Life in Years
|
Aggregate
Intrinsic Value
|
|||||||||||||
Options outstanding at December 31, 2020
|
|
$
|
|
|
$
|
|
||||||||||
Granted
|
|
|
|
$
|
|
|||||||||||
Exercised
|
(
|
)
|
|
|
$
|
|
||||||||||
Forfeited
|
(
|
)
|
|
–
|
$
|
|
||||||||||
Options outstanding at June 30, 2021
|
|
$
|
|
|
$
|
|
||||||||||
Vested and expected to vest at June 30, 2021
|
|
$
|
|
|
$
|
|
||||||||||
Exercisable at June 30, 2021
|
|
$
|
|
|
$
|
|
● |
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 efficiently and effectively conduct our clinical trials;
|
● |
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® + MUC1 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
June 30,
|
Increase (Decrease)
|
|||||||||||||||
2021
|
2020
|
$ Amount
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
2,764
|
$
|
1,414
|
$
|
1,350
|
95
|
%
|
||||||||
General and administrative expenses
|
2,342
|
1,522
|
820
|
54
|
%
|
|||||||||||
Total operating expenses
|
5,106
|
2,936
|
2,170
|
74
|
%
|
|||||||||||
Loss from operations
|
(5,106
|
)
|
(2,936
|
)
|
(2,170
|
)
|
74
|
%
|
||||||||
Interest income
|
1
|
7
|
(6
|
)
|
(86
|
)%
|
||||||||||
Benefit from income taxes
|
4,516
|
–
|
4,516
|
100
|
%
|
|||||||||||
Net loss and comprehensive loss
|
$
|
(589
|
)
|
$
|
(2,929
|
)
|
$
|
2,340
|
(80
|
)%
|
Six Months Ended
June 30,
|
Increase (Decrease)
|
|||||||||||||||
2021
|
2020
|
$ Amount
|
%
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
4,177
|
$
|
3,386
|
$
|
791
|
23
|
%
|
||||||||
General and administrative expenses
|
3,978
|
3,582
|
396
|
11
|
%
|
|||||||||||
Total operating expenses
|
8,155
|
6,968
|
1,187
|
17
|
%
|
|||||||||||
Loss from operations
|
(8,155
|
)
|
(6,968
|
)
|
(1,187
|
)
|
17
|
%
|
||||||||
Interest income, net
|
1
|
53
|
(52
|
)
|
(98
|
)%
|
||||||||||
Benefit from income taxes
|
4,516
|
–
|
4,516
|
100
|
%
|
|||||||||||
Net loss and comprehensive loss
|
$
|
(3,638
|
)
|
$
|
(6,915
|
)
|
$
|
3,277
|
(47
|
)%
|
Six Months Ended June 30,
|
||||||||
2021
|
2020
|
|||||||
Net cash used in operating activities
|
$
|
(2,856
|
)
|
$
|
(7,268
|
)
|
||
Net cash provided by investing activities
|
–
|
–
|
||||||
Net cash provided by financing activities
|
48,766
|
12,040
|
||||||
Net increase in cash
|
$
|
45,910
|
$
|
4,772
|
● |
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 June 30, 2021
|
Total
|
Less than
One Year
|
1-3 Years
|
3-5 Years
|
More than 5
Years
|
|||||||||||||||
Operating lease obligations
|
$
|
552,977
|
$
|
157,663
|
$
|
395,314
|
$
|
–
|
$
|
–
|
||||||||||
Total contractual obligations
|
$
|
552,977
|
$
|
157,663
|
$
|
395,314
|
$
|
–
|
$
|
–
|
ITEM 3: |
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
|
ITEM 4: |
CONTROLS AND PROCEDURES
|
PART II. |
OTHER INFORMATION
|
ITEM 1. |
LEGAL PROCEEDINGS
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ITEM 1A. |
RISK FACTORS
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ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
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ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES
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ITEM 4. |
MINE SAFETY DISCLOSURES
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ITEM 5. |
OTHER INFORMATION
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ITEM 6. |
EXHIBITS
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Exhibit
Number
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Exhibit Description
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10.1 |
Amendment to Employment Agreement by and between PDS Biotechnology Corporation and Gregory Conn, Ph.D., effective as of June 17, 2021 (filed as Exhibit 10.2 to the Company’s Current
Report on Form 8-K filed on June 21, 2021 and incorporated by reference herein).
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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.
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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.
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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).
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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).
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101.INS*
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Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
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101.SCH*
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Inline XBRL Taxonomy Extension Schema Document
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101.CAL*
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Inline XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF*
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Inline XBRL Taxonomy Extension Definition Linkbase Document
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101.LAB*
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Inline XBRL Taxonomy Extension Label Linkbase Document
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101.PRE*
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Inline XBRL Taxonomy Extension Presentation Linkbase Document
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104
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Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
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*
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Filed herewith (unless otherwise noted as being furnished herewith)
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PDS Biotechnology Corporation
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August 12, 2021
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By:
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/s/ Frank Bedu-Addo
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Frank Bedu-Addo
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President and Chief Executive Officer
(Principal Executive Officer)
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August 12, 2021
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By:
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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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