PDS BIOTECHNOLOGY CORP
10-Ks and 10-Qs
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| ☒ |
QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended March 31, 2021
| ☐ |
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from____________to_____________
Commission file number
001-37568
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PDS Biotechnology Corporation
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(Exact name of registrant as specified in its charter)
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Delaware
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26-4231384
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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25B Vreeland Road, Suite 300, Florham Park, NJ 07932
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(Address of principal executive offices)
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(800) 208-3343
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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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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading symbol(s)
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Name of each exchange on which registered
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||
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Common Stock, par value $0.00033 per share
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PDSB
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Nasdaq Capital Market
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large
accelerated filer”, “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer ☐
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Accelerated filer ☐
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Non-accelerated filer ☒
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Smaller Reporting Company ☒
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Emerging growth company ☐
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to
Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares of the registrant’s Common Stock, par value $0.00033 per share, outstanding as of May 7, 2021 was 22,278,261.
PDS BIOTECHNOLOGY CORPORATION
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2021
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Page
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Part I —
Financial Information
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|||
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Item 1.
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Financial Statements (Unaudited):
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1
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2
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3
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4
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5
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Item 2.
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13
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Item 3.
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23
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Item 4.
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23
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Part II —
Other Information
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Item 1.
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24
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Item 1A.
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24
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Item 2.
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24
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Item 3.
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24
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Item 4.
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24
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Item 5.
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24
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Item 6.
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24
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25
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26
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PART 1.
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FINANCIAL INFORMATION
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ITEM 1.
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FINANCIAL STATEMENTS
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
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March 31, 2021
|
December 31, 2020
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||||||
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ASSETS
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(unaudited)
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|||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$
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25,037,374
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$
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28,839,565
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||||
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Prepaid expenses and other
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2,219,514
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1,497,665
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||||||
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Total current assets
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27,256,888
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30,337,230
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||||||
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Property and equipment, net
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3,583
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5,443
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||||||
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Operating lease right-to-use asset
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501,194
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547,706
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Total assets
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$
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27,761,665
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$
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30,890,379
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||||||
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LIABILITIES
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||||||||
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Current liabilities:
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||||||||
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Accounts payable
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$
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950,598
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$
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1,415,224
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||||
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Accrued expenses
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1,854,795
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1,735,322
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||||||
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Operating lease obligation-short term
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123,654
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119,904
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||||||
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Total current liabilities
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2,929,047
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3,270,450
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Noncurrent liability:
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||||||||
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Operating lease obligation-long term
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458,291
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490,353
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||||||
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Total Liabilities:
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$
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3,387,338
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$
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3,760,803
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STOCKHOLDERS’ EQUITY
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||||||||
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Common stock, $
0.00033
par value,
75,000,000
shares authorized at
March 31, 2021
and
December 31, 2020,
22,278,261 shares and
22,261,619
shares issued and
outstanding at
March 31, 2021
and
December 31, 2020
,
respectively
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7,346
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7,346
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||||||
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Additional paid-in capital
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71,200,684
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70,907,315
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Accumulated deficit
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(46,833,703
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)
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(43,785,085
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)
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Total stockholders’ equity
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24,374,327
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27,129,576
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||||||
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Total liabilities and stockholders’ equity
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$
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27,761,665
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$
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30,890,379
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||||
See accompanying notes to the condensed consolidated financial statements.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(Unaudited)
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Three Months Ended March 31,
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2021
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2020
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Operating expenses:
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Research and development expenses
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$
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1,413,057
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$
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1,971,679
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General and administrative expenses
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1,636,216
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2,060,148
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Total operating expenses
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3,049,273
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4,031,827
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Loss from operations
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(3,049,273
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)
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(4,031,827
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)
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||||
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Other income
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||||||||
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Interest income
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655
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46,419
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||||||
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Net loss and comprehensive loss
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$
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(3,048,618
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)
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$
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(3,985,408
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)
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Per share information:
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Net loss per share, basic
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$
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(0.14
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)
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$
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(0.39
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)
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Net loss per share, diluted
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$
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(0.14
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)
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$
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(0.39
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)
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Weighted average common shares outstanding, basic
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22,263,838
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10,314,761
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||||||
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Weighted average common shares outstanding, diluted
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22,263,838
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10,314,761
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||||||
See accompanying notes to the condensed consolidated financial statements.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(Unaudited)
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Common Stock
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Additional
Paid-in
Capital
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||||||||||||||||||
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Shares
Issued
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Amount
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Accumulated
Deficit
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Total Equity
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|||||||||||||||||
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Balance - December 31, 2019
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5,281,237
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$
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1,742
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$
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40,633,670
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$
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(28,937,705
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)
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$
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11,697,707
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||||||||||
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Stock based compensation expense
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–
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–
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124,992
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–
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124,992
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|||||||||||||||
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Issuance of common stock, net of issuance costs
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10,000,000
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3,299
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11,966,703
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–
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11,970,002
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|||||||||||||||
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Issuance of common stock for warrant exercise
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65,240
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22
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70,437
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–
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70,459
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|||||||||||||||
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Issuance of common stock from 401K match
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3,968
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1
|
9,799
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–
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9,800
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|||||||||||||||
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Net loss
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–
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–
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–
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(3,985,408
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)
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(3,985,408
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)
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|||||||||||||
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Balance - March 31, 2020
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15,350,445
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$
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5,064
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$
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52,805,601
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$
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(32,923,113
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)
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$
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19,887,552
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||||||||||
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Common Stock
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Additional
Paid-in
Capital
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||||||||||||||||||
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Shares
Issued
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Amount
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Accumulated
Deficit
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Total Equity
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|||||||||||||||||
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Balance - December 31, 2020
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22,261,619
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$
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7,346
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$
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70,907,315
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$
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(43,785,085
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)
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$
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27,129,576
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||||||||||
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Stock-based compensation expense
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–
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–
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257,622
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–
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257,622
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|||||||||||||||
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Issuance of common stock from 401K match
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16,642
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–
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35,747
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–
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35,747
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|||||||||||||||
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Net loss
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–
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–
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–
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(3,048,618
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)
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(3,048,618
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)
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|||||||||||||
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Balance - March 31, 2021
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22,278,261
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$
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7,346
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$
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71,200,684
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$
|
(46,833,703
|
)
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$
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24,374,327
|
||||||||||
See accompanying notes to the condensed consolidated financial statements.
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(Unaudited)
|
Three Months Ended March 31,
|
||||||||
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2021
|
2020
|
|||||||
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Cash flows from operating activities:
|
||||||||
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Net loss
|
$
|
(3,048,618
|
)
|
$
|
(3,985,408
|
)
|
||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
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Stock-based compensation expense
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257,622
|
124,992
|
||||||
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Stock-based 401K company common match
|
35,747
|
9,800
|
||||||
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Depreciation expense
|
1,860
|
3,902
|
||||||
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Operating lease expense
|
60,257
|
-
|
||||||
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Changes in assets and liabilities:
|
||||||||
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Prepaid expenses and other assets
|
(721,849
|
)
|
(570,916
|
)
|
||||
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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
|
||||
See accompanying notes to the condensed consolidated financial statements.
PDS Biotechnology Corporation, a Delaware corporation (the “Company” or “PDS”), is a clinical-stage immunotherapy company developing
a
growing pipeline of cancer immunotherapies and infectious disease vaccines designed to overcome the well-established limitations of current immunotherapy technologies.
PDS owns Versamune
®
, a proprietary T-cell activating platform designed to train the immune system to better attack and destroy disease. When paired with an
antigen, which is a disease-related protein that is recognizable by the immune system, Versamune
®
has been shown to induce,
in vivo,
large quantities of high-quality, highly potent polyfunctional CD8+ killer T-cells, a specific sub-type of CD8+ killer T-cell that is more effective at killing infected or target cells. Our
immuno-oncology products can potentially be used as a component of combination products with other leading technologies to provide effective treatments across a range of cancer types.
We believe our product candidates are of interest for
potential in relation to Human Papillomavirus, or HPV,- associated cancers, melanoma, colorectal, lung, breast and prostate cancers or as monotherapies in early-stage disease.
PDS is
working to expand its infectious disease pandemic development program, which includes novel vaccines for COVID-19 and universal influenza.
From the Company’s inception, it has devoted substantially all of its efforts to drug development, business planning, engaging regulatory, manufacturing and other technical consultants, acquiring
operating assets, planning and executing clinical trials and raising capital.
On March 15, 2019, the Company, then operating as Edge Therapeutics, Inc. (“Edge”), completed its reverse merger with privately held PDS Biotechnology Corporation (“Private PDS”), pursuant to and
in accordance with the terms of the Agreement and Plan of Merger, dated as of November 23, 2018, as amended on January 24, 2019, by and among the Company, Echos Merger Sub, a wholly-owned subsidiary of the Company (“Merger Sub”), and Private PDS,
whereby Private PDS merged with and into Merger Sub, with Private PDS surviving as the Company’s wholly-owned subsidiary (the “Merger”).
In connection with and immediately following completion of the Merger,
the Company effected a 1-for-20 reverse stock split (the “Reverse Stock Split”) and changed its corporate name from Edge Therapeutics, Inc. to PDS Biotechnology Corporation, and Private PDS changed its name to PDS Operating Corporation.
For accounting purposes, the Merger was treated as a “reverse acquisition” under generally accepted accounting principles in the United States (“U.S. GAAP”) and Private PDS is considered the
accounting acquirer. Accordingly, upon consummation of the Merger, the historical financial statements of Private PDS became the Company’s historical financial statements, and the historical financial statements of Private PDS are included in the
comparative prior periods. As part of the Merger, the Company acquired all of Edge’s assets relating to current and future research and development.
In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as
COVID-19, that has now spread globally. On January 30, 2020, the World Health Organization (WHO) declared COVID-19 a public health emergency. The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under
section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 outbreak. On March 11, 2020, the WHO declared COVID-19 a pandemic and on March 13 the President declared a national emergency in response to the pandemic.
The full impact of the COVID-19 pandemic is unknown and rapidly evolving. The COVID-19 pandemic has and could continue to negatively affect the Company’s liquidity and operations. To date, two of the three recently initiated PDS0101 clinical
trials were delayed, specifically as a result of the adverse impact the COVID-19 pandemic has had on clinical trial operations for cancer indications in the United States. The FDA issued and since updated guidance to assist sponsors in assuring the
safety of trial participants, maintaining compliance with Good Clinical Practice (GCP) and minimizing risks to trial integrity. Clinical trial sites have implemented institution-specific measures securing the safety of patients and staff to ensure
the integrity of the trials in the face of the ongoing pandemic. All three studies have since been initiated despite the pandemic challenges; however, the evolving COVID-19 pandemic has impacted the pace of enrollment in clinical trials in general
and we may be negatively affected with our trials. COVID-19 related travel and other restrictions may also impact the potential for on-site monitoring visiting and audits and inspections by us, third parties, and regulators. There may be shortages
of site personnel and equipment necessary for the timely completion of our trials. We are providing support to address these challenges, but these mitigation measures may not overcome the obstacles that the pandemic has wrought which continue to
impede progress of clinical trials.
Although there is uncertainty related to the anticipated impact of the COVID-19 pandemic on our future results, we believe our current cash reserves, leave us well-positioned to manage our business
through this crisis as it continues to unfold. However, the impacts of the COVID-19 pandemic are broad-reaching and continuing and the financial impacts associated with the COVID-19 pandemic are still uncertain.
Despite the economic uncertainty resulting from the COVID-19 pandemic, we intend to continue to focus on the development of our product candidates and we have expanded our infectious disease
pipeline since the pandemic brought renewed resources and interest in technologies such as the Versamune® platform in the context of research and development in prevention of COVID-19. We are working with a consortium of partners in Brazil to
develop PDS0203; a vaccine for the prevention of COVID-19. This consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil to fund up to approximately
US$60 million to support the clinical development and commercialization of a Versamune®-based COVID-19 vaccine in Brazil.
Note 2 – Summary of Significant Accounting Policies
| (A) |
Unaudited interim financial statements:
|
The interim balance sheet at March 31, 2021, the statements of operations and comprehensive loss and changes in stockholders’ equity for the three months ended March 31, 2021 and 2020, and cash
flows for the three months ended March 31, 2021 and 2020 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, in accordance with the requirements of the Securities
and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial
statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its
financial information. The results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The
balance sheet as of December 31, 2020 included herein was derived from the audited condensed consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s
audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2020, filed by the Company with the SEC in its Annual Report on Form 10-K on March 18, 2021.
| (B) |
Use of estimates:
|
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the consolidated financial statements. Actual
results could differ from those estimates.
| (C) |
Significant risks and uncertainties:
|
The Company’s operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the clinical and regulatory
development of its products, the Company’s ability to preserve its cash resources, the Company’s review of strategic alternatives, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, competition
from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements
for its products, the Company’s ability to raise capital, and the effects of health epidemics, pandemics, or outbreaks of infectious diseases, including the recent COVID-19 pandemic.
The Company currently has no commercially approved products. As such, there can be no assurance that the Company’s future research and development programs will be successfully commercialized.
Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of
rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting its intellectual property.
| (D) |
Cash equivalents and concentration of cash balance:
|
The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company’s cash and cash equivalents in bank deposit
accounts, at times, may exceed federally insured limits.
| (E) |
Research and development:
|
Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and
development projects as well as fees paid to consultants and entities that perform certain research and testing on behalf of the Company.
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment,
clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred.
| (F) |
Patent costs:
|
The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss.
| (G) |
Stock-based compensation:
|
The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees,
directors and non-employees to be recognized as expense in the consolidated statements of operations and comprehensive loss based on their grant date fair values. In order to determine the fair value of stock options on the date of grant, the
Company uses the Black-Scholes option-pricing model. Inherent in this model are assumptions related to expected stock-price volatility, option term, risk-free interest rate and dividend yield. While the risk-free interest rate and dividend yield
are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option term assumptions require a greater level of judgment. The Company expenses the fair value of its stock-based
compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally the vesting period. The Company recognizes forfeitures as they occur.
In lieu of higher cash compensation, the Company has granted non-employee options to consultants and expensed $344 and $0 during the three months ended March 31, 2021 and 2020, respectively.
| (H) |
Net income (loss) per common share:
|
Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the periods. For the
periods presented, the common shares underlying the preferred stock, common stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to
calculate both basic and diluted loss per common share are the same.
The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows:
|
|
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
|
||||||
Note 3 – Liquidity
As of March 31, 2021, the Company had $25.0 million of cash and cash equivalents. The Company’s primary uses of cash are to fund operating expenses, primarily research and development expenditures.
Cash used to fund operating expenses is impacted by the timing of when the Company pays these expenses, as reflected in the change to the Company’s outstanding accounts payable and accrued expenses.
On July 29, 2019, we entered into a common stock purchase agreement, or the Aspire Purchase Agreement, with Aspire Capital pursuant to which, we have the right, in our sole discretion, to present
Aspire Capital Fund, LLC, or Aspire Capital, with a purchase notice, directing Aspire Capital (as principal) to purchase up to 100,000 shares of our common stock per business day, in an aggregate amount of up to $20.0 million of our common stock,
or the Purchased Shares, over the term of the Aspire Purchase Agreement. We may sell an aggregate of 1,034,979 shares of our common stock (which represented 19.99% of our outstanding shares of common stock on the date of the Aspire Purchase
Agreement) without stockholder approval. We may sell additional shares of our common stock above the 19.99% limit provided that (i) we obtain stockholder approval or (ii) stockholder approval has not been obtained at any time the 1,034,979 share
limitation is reached and at all times thereafter the average price paid for all shares issued under the Aspire Purchase Agreement, is equal to or greater than $5.76, which was the consolidated closing bid price of our common stock on July 26,
2019. The minimum price at which we can sell shares under the Aspire Purchase Agreement is $0.50. On July 29, 2019, we issued 100,654 shares of our common stock to Aspire Capital, as consideration for entering into the Aspire Purchase Agreement,
which we refer to as the Commitment Shares. We recorded the fair value of the shares at July 29, 2019 of $603,924 as an expense in the third quarter of 2019. Concurrently with the Aspire Purchase Agreement, we entered into a registration rights
agreement with Aspire Capital, or the Registration Rights Agreement. In accordance with the Registration Rights Agreement, on August 20, 2019 we filed a Registration Statement on Form S-1 (File No. 333-232988) to cover the resale of the Commitment
Shares and any Purchased Shares issuable to Aspire Capital under the Aspire Purchase Agreement. There is market uncertainty regarding the utilization of financing associated from the Aspire Purchase Agreement. As of March 31, 2021, no Purchase
Shares have been sold to Aspire Capital under the Aspire Purchase Agreement.
In February 2020, we completed an underwritten public offering, in which we sold 10,000,000 shares of common stock at a public offering price of $1.30 per share. The shares sold included 769,230
shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions. We received gross proceeds of approximately $13 million and net proceeds of
approximately $11.9 million after deducting underwriting discounts and commissions.
In July 2020, we filed a shelf registration statement, or the 2020 Shelf Registration Statement, with the SEC, for the issuance of common stock, preferred stock, warrants, rights, debt securities
and units, which we refer to collectively as the Shelf Securities, up to an aggregate amount of $100 million. The 2020 Shelf Registration Statement was declared effective on July 31, 2020. On August 13, 2020, the Company sold 6,900,000 shares of
its common stock at a public offering price of $2.75 per share pursuant to the 2020 Shelf Registration Statement, which includes 900,000 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public
offering price, minus underwriting discounts and commissions. We received gross proceeds of approximately $19.0 million and net proceeds of approximately $17.1 million, after deducting underwriting discounts and offering expenses. Approximately
$81,000,000 of Shelf Securities remain available for future sale under the 2020 Shelf Registration Statement.
Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these
expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year beyond the
filing of this Quarterly Report on Form 10-Q. Our budgeted cash requirements in 2021 and beyond include expenses related to continuing development and clinical studies. Based on our available cash resources and cash flow projections as of the
date the consolidated financial statements were available for issuance, we believe there are sufficient funds to continue operations and research and development programs for at least 12 months from the date of this report.
We plan to continue to fund our operations and capital funding needs through equity and/or debt financings. However, the Company cannot be certain that additional financing will be available when
needed or that, if available, financing will be obtained on terms favorable to the Company or its existing stockholders. We may also enter into government funding programs and consider selectively partnering for clinical development and
commercialization. The sale of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and
financing covenants that would restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future
commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and prospects. Failure to obtain
adequate financing also may adversely affect its ability to operate as a going concern.
Note 4 – Fair Value of Financial Instruments
There were no transfers among Levels 1, 2, or 3 during 2021 or 2020.
|
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
|
$
|
–
|
$
|
–
|
||||||||
Note 5 – Leases
On July 8, 2019, the Company entered into a lease termination agreement for its office space located at 300 Connell Drive, Suite 4000, Berkeley Heights, NJ 07922 effective August 31, 2019 (the
“Lease Termination Agreement”). Pursuant to the Lease Termination Agreement, the Company was required to pay 50 percent of the remaining lease payments of $665,802 over three installments on September 1, 2019, December 1, 2019, and March 1, 2020,
which was recorded as lease termination costs in the third quarter of 2019. The Company entered into a temporary month-to-month lease as of September 1, 2019 for office space located at 830 Morris Turnpike, Short Hills, NJ 07078 until the Company
entered into a new lease for permanent office space. This lease was terminated on May 31, 2020.
Effective March 5, 2020, the Company entered into a sublease for approximately 11,200 square feet of office space located at 25B Vreeland Road, Suite 300, Florham Park, NJ. The sublease commenced
on May 1, 2020 and will continue for a term of forty (40) months with an option to renew through October 31, 2027. As of March 31, 2021 there are twenty-nine (29) months remaining in the lease term. Upon inception of the lease, the Company
recognized approximately $0.7 million of a ROU asset and operating lease liabilities. The discount rate used to measure the operating lease liability as of May 1, 2020 was 9.15%. Throughout the period described above the Company has maintained, and
continues to maintain, a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540.
Supplemental cash flow information related to operating leases is as follows:
|
As of March 31,
|
||||||||
|
2021
|
2020
|
|||||||
|
Cash paid for operating lease liabilities
|
$
|
42,057
|
$
|
-
|
||||
|
Right-of use assets recorded in exchange for lease obligations
|
$
|
-
|
$
|
-
|
||||
Maturity of the Company’s operating lease liability is as follows:
|
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
|
|||
Note 6 – Accrued Expenses
Accrued expenses and other liabilities consist of the following:
|
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
|
||||
Note 7 – Stock-Based Compensation
The Company has three equity compensation plans: the 2009 Stock Option Plan, 2014 Equity Incentive Plan and the 2018 Stock Incentive Plan (the “Plans”).
In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock units (“RSUs”), subject
to increases as hereafter described (the “Plan Limit”). In addition, on January 1, 2015 and each January 1 thereafter and prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the
Plan Limit was and shall be increased by the lesser of (x) 4% of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. In
March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares.
In 2018, the Company’s stockholders approved the 2018 Stock Incentive Plan pursuant to which the Company may grant up to 558,071 shares as (i) Stock Options, (ii) Stock Appreciation Rights, (iii)
Restricted Stock, (iv) Preferred Stock, (v) Stock Reload Options and/or (vi) Other Stock-Based Awards.
Pursuant to the terms of the Plans, ISOs have a term of ten years from the date of grant or such shorter term as may be provided in the option agreement. Unless specified
otherwise in an individual option agreement, ISOs generally vest over a four year term and NQs generally vest over one to five year terms. Unless terminated by the Board, the Plans shall continue to remain effective for a term of ten years or until
such time as no further awards may be granted and all awards granted under the Plans are no longer outstanding. As of March 31, 2021, there were 190,799 shares available for grant under the 2018 Stock Incentive Plan.
On June 17, 2019, the Board adopted the 2019 Inducement Plan (the “Inducement Plan”). The Inducement Plan provides for the grant of non-qualified stock options. The Inducement Plan was
recommended for approval by the Compensation Committee of the Board and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
On December 9, 2020, the Company amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 200,000 shares to
500,000 shares. The 2019 Inducement Plan will be administered by the Compensation Committee of the Board. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, non-qualified stock options under the 2019 Inducement Plan may only be made
to an employee who has not previously been an employee or member of the Board (or any parent or subsidiary of the Company), or following a bona fide period of non-employment by the Company (or a parent or subsidiary of the Company), if he or she
is granted such non-qualified stock options in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such
subsidiary. As March 31, 2021, there were 221,200 shares available for grant under the 2019 Inducement Plan.
The Company’s stock-based compensation expense was recognized in operating expense as follows:
|
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
|
||||
The fair value of options and warrants granted during the three months ended March 31, 2021 was estimated using the Black-Scholes option valuation model utilizing the following assumptions:
|
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
|
||||
The following table summarizes the number of options outstanding and the weighted average exercise price:
|
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
|
||||||||||
At March 31, 2021 there was approximately $1,483,195 of unamortized stock option compensation expense, which is expected to be recognized over a remaining average vesting period of 3 years.
Note 8 – Income Taxes
In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more likely than not that some portion or
all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss
carryforwards. The Company expects to have a loss for 2021 and there will be no current income tax expense. Additionally, there was a full valuation allowance against the net deferred tax assets as of March 31, 2021 and December 31, 2020. As such,
the Company recorded no income tax benefit due to realization uncertainties.
The Company’s U.S. statutory rate is 21%. The primary factor impacting the effective tax rate for the three months ended March 31, 2021 is the anticipated full year operating loss which will
require full valuation allowances against any associated net deferred tax assets.
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has
concluded that as of March 31, 2021, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination could apply from that
date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties
for the three months ended March 31, 2021 and for the year ended December 31, 2020.
Note 9 – Commitments and Contingencies
Rent
For month-to-month arrangements not impacted by the adoption of ASC 842, rent for the three months ended March 31, 2021 and 2020, rent was $36,017 and $58,641 respectively.
Note 10 – Retirement Plan
The Company has a 401(k) defined contribution plan for the benefit for all employees and permits voluntary contributions by employees subject to IRS-imposed limitations. The 401(k)
employer contributions were
$35,747 and $9,800 for the three months ended March 31, 2021 and 2020, respectively.
Note 11– Subsequent Events
Subsequent events have been evaluated through the date these financial statements were issued.
| ITEM 2. |
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited
interim condensed consolidated
financial statements and related notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and with the audited financial statements
and notes thereto of the Company as of and for the year ended December 31, 2020 on Form 10-K, filed with the Securities and Exchange Commission, or SEC, on March 18, 2021.
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly
Report, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. In some cases, you can identify forward-looking
statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. These
forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading “Risk Factors” below. In light of these risks, uncertainties and assumptions, actual results could differ
materially and adversely from those anticipated or implied in the forward-looking statements in this Quarterly Report and you should not place undue reliance on these forward-looking statements.
These forward-looking statements may include, but are not limited to, statements about:
|
|
● |
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.
|
Any forward-looking statements in this Quarterly Report reflect our views and assumptions only as of the date that this report is signed with respect to future events or to our future financial
performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by
these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any
reason, even if new information becomes available in the future.
We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Company Overview
We are a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapy and infectious disease vaccine candidates designed to overcome the limitations of current
immunotherapy technologies. Our Versamune
®
technology is a proprietary T-cell activating platform designed to train the immune system to better attack and destroy disease. When paired with an antigen (which is a disease-related protein
that is recognizable by the immune system) Versamune
®
induces,
in vivo,
large quantities of high-quality, highly potent polyfunctional CD8+ killer T-cells, a specific sub-type of CD8+ killer
T-cell that is more effective at killing infected or target cells.
We believe that the Versamune® platform has the potential to become an industry-leading immuno-oncology technology and is currently being applied to the development of a robust pipeline of valuable
“new-generation, multi-functional” immunotherapies, both as single agents and as part of combination therapies with other leading immuno-oncology technologies. We believe our product candidates are of interest for potential combination therapies in
relation to Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers in advanced cancer or as monotherapies in early-stage disease.
It is well documented that the most critical attribute of an effective cancer immunotherapy is the induction of high levels of active antigen-specific CD8+ (killer) T-cells. Priming adequate levels
of active CD8+ T-cells in-vivo continues to be a major obstacle facing immunotherapy. PDS0101 in its first human clinical trial provided data supporting the earlier promising preclinical study results and demonstrated the unique in-vivo induction
of high levels of active HPV-specific CD8+ T-cells in humans.
|
PDS0101 in Combination with KEYTRUDA
®
Clinical Trial:
|
In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 (Versamune
®
with multiple HPV16 antigens) in combination with Merck’s anti-PD-1 therapy,
KEYTRUDA
®
(pembrolizumab) for first-line treatment of recurrent/ metastatic head and neck cancer opened and is actively recruiting patients. The clinical trial will evaluate the efficacy and safety of this therapeutic combination as a
first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection. In June 2019, the FDA approved using KEYTRUDA
®
in combination with platinum and fluorouracil
(FU) for all patients for first line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma, or HNSCC, and as a single agent for patients whose tumors express PD-L1 as determined by an FDA-approved
test.
In this sponsored trial, patients whose cancer has returned or spread following initial treatment, will be able to avoid chemotherapy and take this combination of two immuno-therapy drugs.
Enrolling patients with more functional immune systems that have not been compromised by extensive chemotherapy may allow improved efficacy of the combination. Patients in the study will receive a total of 5 cycles of combination therapy in the
context of standard of care KEYTRUDA™ therapy administered every three weeks until disease progression. The primary endpoint of VERSATILE-002 is the objective response rate – or ORR – at nine months following initiation of treatment. There will
be a lead-in cohort of 12 patients to assess the safety of the combination, and a formal planned interim analysis evaluating response to treatment in the first 38 patients. Sites have implemented institution-specific measures securing the safety of
patients and staff to ensure the integrity of the study in the face of the ongoing pandemic. The study’s Lead Principal Investigator is Dr. Jared Weiss, who serves as the section chief of Thoracic and Head and Neck/Neck Oncology at the University
of North Carolina School of Medicine Lineberger Comprehensive Cancer Care Center. This trial is actively recruiting patients.
PDS0101 in Combination with Bintrafusp alfa (M7824) and NHS-IL12 Clinical Trial:
In June 2020, the first patient was dosed under a PDS0101 Cooperative Research and Development Agreement, which we refer to as the CRADA, in a National Cancer Institute, or NCI, led Phase 2
clinical study evaluating PDS0101, NHS-IL12, and M7824, owned by EMD Serono (Merck KGaA).
On April 28, 2021 we announced that initial efficacy and safety data from this study was accepted for oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting
taking place in early June. Preclinical study results arising from this CRADA were published in the Journal for ImmunoTherapy of Cancer,
Immunomodulation to enhance the efficacy of and HPV therapeutic vaccine
(Journal for ImmunoTherapy of Cancer 2020;8:e000612. doi:10.1136/ jitc-2020-000612)
, indicating that PDS0101 generated both HPV-specific T-cells and an associated antitumor response when used as a
monotherapy. When PDS0101 was combined with two other novel clinical-stage anti-cancer agents, Bintrafusp alfa (M7824) and NHS-IL12 preclinical data suggested that all three therapeutic agents worked synergistically to provide enhanced tumor
T-cell response and subsequent tumor regression and when compared to any of the agents alone or 2-component combinations. If this preclinical data is successfully confirmed in the ongoing Phase 2 trial, this triple combination could form the
basis of a unique platform providing improved cancer treatments across multiple cancers.
This investigator-led study has achieved its initial safety benchmark – meaning that not more than 1 dose-limiting toxicity was observed in the first 6 patients who received the combination. In
February 2021, we announced that this trial achieved its preliminary objective response target in patients naïve to checkpoint inhibitors. The trial is progressing to full enrollment of approximately 20 patients in this group. In addition, the
trial was amended to allow enrollment of a separate cohort of checkpoint inhibitor-refractory patients, or patients who have received prior treatment with checkpoint inhibitors, for assessment of safety and activity of the triple combination.
Preliminary efficacy assessment of the triple combination in this added group of 20 checkpoint inhibitor refractory patients is ongoing.
PDS0101 in Combination with Chemo-Radiotherapy Clinical Trial:
In October 2020, a third PDS0101 Phase 2 clinical trial was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients. This clinical trial is
investigating the safety and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer. PDS
believes that Versamune
®
’s strong T-cell induction has the potential to meaningfully enhance efficacy of the current standard of care CRT treatment in this indication.
|
Other Versamune
®
Products Under Development:
|
|
PDS0102 – Versamune
®
+ TARP antigens
|
The TARP antigen is over-expressed in acute myelogenous leukemia (AML), prostate and breast cancers. In the U.S. 450,000 patients are projected to be diagnosed with prostate or breast cancer this
year. Approximately 90% of prostate cancers and 50% of breast cancers overexpress the TARP tumor antigen. In the U.S. 19,900 patients are projected to be diagnosed with AML this year. 100% of AML overexpress the TARP tumor antigen. In a human
clinical study, the National Cancer Institute demonstrated that its proprietary TARP antigens were effectively recognized by the immune system in prostate cancer patients with PSA biochemical recurrence leading to a notable reduction in tumor
growth rate. In preclinical studies, a dramatically enhanced TARP-specific killer T-cell response was observed when our designed TARP antigens were combined with Versamune® (PDS0102). Preclinical development is ongoing.
|
PDS0103 – Versamune
®
+ MUC-1 antigens
|
In April 2020, the PDS-NCI CRADA was expanded beyond PDS0101 to include clinical and preclinical development of PDS0103. PDS0103 is an investigational immunotherapy owned by us and designed to
treat cancers associated with the mucin-1, or MUC-1, oncogenic protein. PDS0103 combines Versamune
®
with novel highly immunogenic agonist epitopes of MUC-1 developed by the NCI and licensed by PDS. MUC1 is highly expressed in several
types of cancer and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed. In preclinical studies, and similarly to PDS0101, PDS0103
demonstrated the ability to generate powerful MUC-1-specific CD8 killer T-cells. PDS0103 is currently in late preclinical development.
|
PDS0104 – Versamune
®
+ TRP-2 and melanoma antigens
|
The rates of melanoma have been rising rapidly over the past few decades and approximately 96,480 new melanomas will be diagnosed this year alone. More than 7,000 of these will prove fatal. PDS0104
combines Versamune ® with various melanoma antigens including the Tyrosinase-related protein 2 (TRP2) which is highly expressed in melanoma. PDS0104 has been demonstrated in pre-clinical animal models of aggressive melanoma to have unique and
significant anti-tumor activity as a monotherapy and has also demonstrated strong anti-tumor synergy in combination with checkpoint inhibitors. Preclinical development is ongoing.
Infectious Diseases
Our focus remains on developing our oncology products and progressing clinical trials described above, however we are also developing preventative vaccines to address several infectious diseases.
Based on the key characteristics of Versamune
®
we are progressing preclinical development of PDS0202, a universal influenza vaccine candidate, which combines Versamune
®
with novel influenza vaccine antigens. PDS0202
pre-clinical development is being supported by an agreement with the National Institute of Allergy and Infectious Diseases Collaborative Influenza Vaccine Innovation Centers, or CIVICs, program, with a goal of progressing into a human clinical
trial.
PDS0203 is being designed with the goal to potentially provide long-term and broad protection against infection from COVID-19 and its potential mutations. This second generation COVID-19 vaccine
is based on the understood potential of Versamune
®
to prime the immune system to generate both antibodies for near term protection and T-cell responses for long term protection against pathogens. We are jointly developing PDS0203 under
a collaboration agreement with Farmacore.
On March 11, 2021, we announced that the COVID-19 vaccine consortium consisting of PDS, Farmacore Biotechnology and Blanver Farmoquímica, received a commitment from the Secretary for Research and
Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (“MCTI”) to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune®-based COVID-19 vaccine in Brazil. We
are advised that MCTI intends to make a portion of the funding available, upon authorization by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (Anvisa) to initiate a combined Phase 1/2 clinical trial in Brazil. The
majority of the capital provided by MCTI will fund the manufacturing process scale up, production and the Phase 3 trial, pending the results of the Phase 1/2 trial. All funding is contingent on the availability of financial resources within the
MCTI, understanding that the public health response and political situation in Brazil is constantly evolving.
The pre-Investigational Medicinal Product Dossier, or “pre-IMPD” package for the Phase 1/2 trial is currently under review by Anvisa and the trial is anticipated to begin by the end of this year.
The majority of the capital provided by MCTI will fund the manufacturing process scale up, production and the Phase 3 trial, pending the results of the Phase 1/2 trial. The Phase 1 and 2 trials, which will be run together, are anticipated to
enroll approximately 360 patients and will assess the safety and efficacy of the vaccine as well as both the antibody and killer T-cell responses induced by the vaccine to the novel coronavirus. The clinical trials are planned to be conducted in
Brazil.
As the license holder of PDS0203 in Latin America, Farmacore Biotechnology will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research
organization, to conduct clinical trials in Brazil. We will continue to contribute scientific expertise and operational support. Blanver Farmoquímica will manufacture, promote, distribute, and commercialize the Versamune®-based COVID-19 vaccine
in Latin America.
In December 2019, we entered into an Amended and Restated Material Transfer Agreement (MTA) with Farmacore to develop a novel tuberculosis, or TB, immunotherapy based on a combination of
Farmacore’s proprietary TB antigens with Versamune®. In preliminary evaluations, our Versamune®-based TB product, PDS0201, demonstrated highly promising TB-specific T-cell induction in-vivo. Under the Farmacore MTA, we will undertake product
development and Farmacore will conduct in-vivo preclinical studies to evaluate product efficacy.
We continue to primarily devote the majority of our resources and attention on the clinical oncology assets and execution of our oncology programs. Our current pipeline of Versamune®-based
therapies is as follows:
From the Company’s inception, it has devoted substantially all of its efforts to drug development, business planning, engaging regulatory, manufacturing and other technical consultants, acquiring
operating assets, planning and executing clinical trials and raising capital. We currently operate the existing business of Private PDS (as defined below) as a publicly traded company under the name PDS Biotechnology Corporation. We were
incorporated as Edge Therapeutics, Inc., or Edge, on January 22, 2009. On March 15, 2019, privately held PDS Biotechnology Corporation, or Private PDS, completed a reverse merger, or the Merger, with Edge, pursuant to which Private PDS survived as
a wholly owned subsidiary of Edge. Under the terms of the Merger, Edge changed its name to PDS Biotechnology Corporation and Private PDS changed its name to PDS Biotechnology Corporation.
We have never been profitable and have incurred net losses in each year since inception. Our net losses were $3.0 million, and $4.0 million for the three months ended March 31, 2021 and 2020,
respectively. As of March 31, 2021, we had an accumulated deficit of $46.8 million. Substantially all of our net losses have resulted from costs incurred in connection with its research and development programs and from general and administrative
costs associated with these operations.
As of March 31, 2021, we had $25.0 million in cash and cash equivalents.
Our future funding requirements will depend on many factors, including the following:
|
|
● |
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.
|
KEY COMPONENTS OF OUR STATEMENT OF OPERATIONS
Revenue
We have not generated any revenues from commercial product sales and do not expect to generate any such revenue in the near future. We may generate revenue in the future from a combination of
research and development payments, license fees and other upfront payments or milestone payments.
Research and Development Expenses
Research and development expenses include employee-related expenses, licensing fees to use certain technology in our research and development projects, costs of acquiring, developing and
manufacturing clinical trial materials, as well as fees paid to consultants and various entities that perform certain research and testing on our behalf. Costs for certain development activities, such as clinical trials, are recognized based on an
evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of
the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued expenses. Costs incurred in connection with research and development activities are
expensed as incurred.
We expect that our research and development expenses will increase significantly over the next several years as we advance our Versamune®-based immuno-oncology, or I-O, candidates into and through
clinical trials, pursues regulatory approval of our injectable Versamune® candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract and internal manufacturing and inventory related
costs.
The process of conducting human clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for our injectable I-O
candidates. The probability of successful commercialization of our I-O candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and commercial viability. As a result,
we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Results of Operations
The following table summarizes the results of our operations for the three months ended March 31, 2021 and 2020:
|
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
|
)%
|
||||||
Research and Development Expenses
Research and development (R&D) expenses decreased to $1.4 million for the three months ended March 31, 2021 from $2.0 million for the three months ended March 31, 2020. The decrease of $0.6
million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.
General and Administrative Expenses
General and administrative expenses decreased to $1.6 million
for the three months ended March 31, 2021
from $2.1 million
for the three months ended March 31, 2020
. The decrease of $0.5 million is primarily attributable to a decrease in professional services of $0.7 million which includes legal fees of
$0.2 million, offset by an increase of $0.2 million in personnel costs.
Interest income
Interest income, net was $0.001 million during the three months ended March 31, 2021, an decrease of $0.045 million, as compared to $0.046 million during the three months ended March 31, 2020, due
primarily to interest received on invested cash and cash equivalents.
Liquidity and Capital Resources
On July 29, 2019, we entered into a common stock purchase agreement, or the Aspire Purchase Agreement, with Aspire Capital pursuant to which, we have the right, in our sole discretion, to present
Aspire Capital Fund, LLC, or Aspire Capital, with a purchase notice, directing Aspire Capital (as principal) to purchase up to 100,000 shares of our common stock per business day, in an aggregate amount of up to $20.0 million of our common stock,
or the Purchased Shares, over the term of the Aspire Purchase Agreement. We may sell an aggregate of 1,034,979 shares of our common stock (which represented 19.99% of our outstanding shares of common stock on the date of the Aspire Purchase
Agreement) without stockholder approval. We may sell additional shares of our common stock above the 19.99% limit provided that (i) we obtain stockholder approval or (ii) stockholder approval has not been obtained at any time the 1,034,979 share
limitation is reached and at all times thereafter the average price paid for all shares issued under the Aspire Purchase Agreement, is equal to or greater than $5.76, which was the consolidated closing bid price of our common stock on July 26,
2019. The minimum price at which we can sell shares under the Aspire Purchase Agreement is $0.50. On July 29, 2019, we issued 100,654 shares of our common stock to Aspire Capital, as consideration for entering into the Aspire Purchase Agreement,
which we refer to as the Commitment Shares. We recorded the fair value of the shares at July 29, 2019 of $603,924 as an expense in the third quarter of 2019. Concurrently with the Aspire Purchase Agreement, we entered into a registration rights
agreement with Aspire Capital, or the Registration Rights Agreement. In accordance with the Registration Rights Agreement, on August 20, 2019 we filed a Registration Statement on Form S-1 (File No. 333-232988) to cover the resale of the Commitment
Shares and any Purchased Shares issuable to Aspire Capital under the Aspire Purchase Agreement. There is market uncertainty regarding the utilization of financing associated from the Aspire Purchase Agreement. As of March 31, 2021, no Purchase
Shares have been sold to Aspire Capital under the Aspire Purchase Agreement.
In February 2020, we completed an underwritten public offering, in which we sold 10,000,000 shares of common stock at a public offering price of $1.30 per share. The shares sold included 769,230
shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions. We received gross proceeds of approximately $13 million and net proceeds of
approximately $11.9 million after deducting underwriting discounts and commissions.
In July 2020, we filed a shelf registration statement, or the 2020 Shelf Registration Statement, with the SEC, for the issuance of common stock, preferred stock, warrants, rights, debt securities
and units, which we refer to collectively as the Shelf Securities, up to an aggregate amount of $100 million. The 2020 Shelf Registration Statement was declared effective on July 31, 2020. On August 13, 2020, we sold 6,900,000 shares of its common
stock at a public offering price of $2.75 per share pursuant to the 2020 Shelf Registration Statement, which includes 900,000 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering
price, minus underwriting discounts and commissions. We received gross proceeds of approximately $19.0 million and net proceeds of approximately $17.1 million, after deducting underwriting discounts and offering expenses. Approximately $81,000,000
of Shelf Securities remain available for future sale under the 2020 Shelf Registration Statement.
Our operations have also been financed from cash of $29.1 million from the consummation of the Merger in March 2019. As of March 31, 2021, we had $25.0 million of cash and cash equivalents.
Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these
expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the
filing of this Quarterly Report on Form 10-Q. Our budgeted cash requirements in 2021 and beyond include expenses related to continuing development and clinical studies. Based on our available cash resources and cash flow projections as of the
date the consolidated financial statements were available for issuance, we believe there are sufficient funds to continue operations and research and development programs for at least 12 months from the date of this Quarterly Report on Form 10-Q.
We plan to continue to fund our operations and capital funding needs through equity and/or debt financings. However, we cannot be certain that additional financing will be available when needed or
that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale
of additional equity would result in additional dilution to our stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would
restrict our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights
to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and prospects. Failure to obtain adequate financing also may adversely affect
its ability to operate as a going concern.
Cash Flows
The following table shows a summary of our cash flows for each of the periods indicated (in thousands):
|
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
|
|||
Net Cash Used in Operating Activities
Net cash used in operating activities was $3.8 million and $3.2 million for the three months ended March 31, 2021and 2020, respectively. The increase in cash used in operating activities of $0.6
million was primarily due to the increase of prepaid expenses related to the Syneos CRO contract.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2020 was due to the receipt of net proceeds from the issuance of common stock of $12.0 million.
Operating Capital Requirements
To date, we have not generated any product revenue. We do not know when, or if, we will generate any product revenue and we do not expect to generate significant product revenue unless and until we
obtain regulatory approval and commercialize one of our current or future product candidates. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of,
and seek regulatory approvals for, our tablet vaccine candidates, and begin to commercialize any approved vaccine candidates. We are subject to all of the risks incident to the development of new products, and may encounter unforeseen expenses,
difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating as a public company and anticipate that we will need substantial additional funding in
connection with our continuing operations.
We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year beyond the
filing of this Quarterly Report. Our budgeted cash requirements in 2021 and beyond include expenses related to continuing development and clinical studies. We believe that our existing cash and cash equivalents as of December 31, 2020 are
sufficient to continue operations and research and development programs for at least the next 12 months from the date of this Quarterly Report. Until we can generate significant cash from our operations, we expect to continue to fund our operations
with available financial resources. These financial resources may not be adequate to sustain our operations.
We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of
the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will
depend on many factors, including, but not limited to:
|
|
● |
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.
|
Please see the section titled “Risk Factors” in this Quarterly Report on Form 10-Q for additional risks associated with our operations.
Contractual Obligations and Commitments
The following is a summary of our contractual obligations as of the date indicated:
|
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
|
$
|
–
|
$
|
–
|
||||||||||
Purchase Commitments
We have no material non-cancelable purchase commitments with service providers as we have generally contracted on a cancelable, purchase order basis.
Critical Accounting Polices and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The
preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as
well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2021 from those disclosed in our Annual Report on Form 10-K for the
year ended December 31, 2020.
Impact of the CARES Act
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, was enacted and signed into law, and GAAP requires recognition of the tax effects of new legislation
during the reporting period that includes the enactment date. The CARES Act, among other things, includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act,
including, permitting net operating losses, or NOLs, carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019, and 2020 to be carried back to
each of the five preceding taxable years to generate a refund of previously paid income taxes. The CARES Act provides other reliefs and stimulus measures. We have evaluated the impact of the CARES Act, and do not expect that any provision of the
CARES Act would result in a material cash benefit to us or have a material impact on our financial statements or internal controls over financial reporting.
Operations and Liquidity
While the potential economic impact brought by and over the duration of the COVID-19 pandemic may be difficult to assess or predict, the COVID-19 pandemic has resulted in significant disruption of
global financial markets, which could in the future negatively affect our liquidity. In addition, a recession or market volatility resulting from the COVID-19 pandemic could affect our business. We have taken proactive, aggressive action throughout
the COVID-19 pandemic to protect the health and safety of our employees and expect to continue to implement these measures until we determine that the COVID-19 pandemic is adequately contained for purposes of our business. We may take further
actions as government authorities require or recommend or as we determine to be in the best interests of our employees. Given the nature and type of our short-term investments, we do not believe that the COVID-19 pandemic will have a material
impact on our current investment liquidity.
Outlook and Impact of COVID-19 on our Business
In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as
COVID-19, that has now spread globally. On January 30, 2020 the World Health Organization (WHO) declared COVID-19 a public health emergency. The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under
section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to the COVID-19 outbreak. On March 11, 2020, the WHO declared COVID-19 a pandemic. The full impact of the COVID-19 pandemic is unknown and rapidly evolving. The COVID-19
pandemic has and could continue to negatively affect the Company’s liquidity and operations. To date, two of the three currently planned PDS0101 clinical trials have been delayed, specifically as a result of the adverse impact the COVID-19
pandemic has had on clinical trial operations for cancer indications in the United States. Even though both of these studies have since been initiated despite the pandemic challenges, the evolving COVID-19 pandemic has also impacted the pace of
enrollment in clinical trials and we may be affected by similar delays as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff can no longer get
to the clinic.
Although there is uncertainty related to the anticipated impact of the COVID-19 pandemic on our future results, we believe our current cash reserves, leave us well-positioned to manage our business
through this crisis as it continues to unfold. However, the impacts of the COVID-19 pandemic are broad-reaching and continuing and the financial impacts associated with the COVID-19 pandemic are still uncertain.
Despite the economic uncertainty resulting from the COVID-19 pandemic, we intend to continue to focus on the development of our product candidates and we have expanded our infectious disease
pipeline since the pandemic brought renewed resources and interest on technologies such as the Versamune® platform in the context of research and development in prevention of COVID-19. We are working with a consortium of partners in Brazil to
develop PDS0203; a vaccine for the prevention of COVID-19. This consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil to fund up to approximately
US$60 million to support the clinical development and commercialization of a Versamune®-based COVID-19 vaccine in Brazil.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Smaller Reporting Company
As of January 1, 2021, we are no longer an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. However, we remain a “smaller reporting
company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended. We will cease to be a smaller reporting company if we have a non-affiliate public float in excess of $250 million and annual revenues in excess of $100
million, or a non-affiliate public float in excess of $700 million, determined on an annual basis. Even though we no longer qualify as an emerging growth company, we may still qualify as a smaller reporting company. As a smaller reporting company,
we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies. We expect to continue to take advantage of some or all of the available
exemptions.
| ITEM 3: |
The primary objectives of our investment activities are to ensure liquidity and to preserve principal, while at the same time maximizing the income we receive from our cash and marketable
securities without significantly increasing risk. As of March 31, 2021, we had cash equivalents of $25.0 million that were held in a non-interest-bearing money operating account and an institutional U.S. Treasury money market fund. Our primary
exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and the low risk profile of our investments, we do not believe
that an immediate 100 basis point change in interest rates would have a material effect on the fair market value of our cash equivalents. To minimize the risk in the future, we intend to maintain our portfolio of cash equivalents and short-term
investments in institutional market funds that are comprised of U.S. Treasury and Treasury backed repurchase agreements.
| ITEM 4: |
Evaluation of Disclosure Controls and Procedures
An evaluation was carried out, under the supervision of and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness
of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15 (e)) under the Securities Exchange Act of 1934, or the Exchange Act, as of the end of the period covered by this report. Based on the evaluation, our Chief
Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures are effective to ensure that the information required to be disclosed by us in the reports we file or submit under the Exchange Act was
recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the evaluation identified
above that occurred during the quarter ended March 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| PART II. |
OTHER INFORMATION
|
| ITEM 1. |
From time to time, PDS may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. Litigation, regardless of the outcome, could have an
adverse impact on PDS because of defense and settlement costs, diversion of management resources and other factors. PDS is not currently a party to any legal proceedings, the adverse outcome of which, in PDS’s management’s opinion, individually or
in the aggregate, would have a material adverse effect on PDS’s results of operations or financial position.
| ITEM 1A. |
There have been no material changes from our risk factors as previously reported in our Annual Report on Form 10-K for the year ended December 31, 2020. However, any investment in our business
involves a high degree of risk. Before making an investment decision, you should carefully consider the information we include in this Quarterly Report on Form 10-Q, including our unaudited interim condensed consolidated financial statements and
accompanying notes, our Annual Report on Form 10-K for the year ended December 31, 2020 filed on March 18, 2021, including our financial statements and related notes contained therein, and the additional information in the other reports we file
with the Securities and Exchange Commission. These risks may result in material harm to our business and our financial condition and results of operations. In this event, the market price of our common stock may decline and you could lose part or
all of your investment.
Additional risks that we currently believe are immaterial may also impair our business operations. Our business, financial conditions and future prospects and the trading price of our
common stock could be harmed as a result of any of these risks.
| ITEM 2. |
There were no unregistered sales of the Company’s equity securities during the three months ended March 31, 2021.
| ITEM 3. |
None.
| ITEM 4. |
Not applicable.
| ITEM 5. |
None.
| 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
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101.PRE*
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XBRL Taxonomy Extension Presentation Linkbase Document
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* Filed herewith (unless otherwise noted as being furnished herewith)
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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PDS Biotechnology Corporation
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May 13, 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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May 13, 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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TABLE OF CONTENTS
Part 1Item 1. Financial StatementsNote 1 Nature Of OperationsNote 2 Summary Of Significant Accounting PoliciesNote 3 LiquidityNote 4 Fair Value Of Financial InstrumentsNote 5 LeasesNote 6 Accrued ExpensesNote 7 Stock-based CompensationNote 8 Income TaxesNote 9 Commitments and ContingenciesNote 10 Retirement PlanNote 11 Subsequent EventsItem 2. Management S Discussion and Analysis Of Financial Condition and Results Of OperationsItem 3: Quantitative and Qualitative Disclosure About Market RiskItem 4: Controls and ProceduresPart II. Other InformationItem 1. Legal ProceedingsItem 1A. Risk FactorsItem 2. Unregistered Sales Of Equity Securities and Use Of ProceedsItem 3. Defaults Upon Senior SecuritiesItem 4. Mine Safety DisclosuresItem 5. Other InformationItem 6. Exhibits