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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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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| Item 2.02 |
Results of Operation and Financial Condition.
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| Item 8.01 |
Other Events.
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| Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
Number
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Description
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Press Release May 11, 2022.
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Corporate Presentation May 2022.
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104
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Cover Page Interactive Data File - the cover page interactive date file does not appear in the Interactive Date File because its XBRL tags are embedded within the Inline XBRL document.
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PDS BIOTECHNOLOGY CORPORATION
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Date: May 11, 2022
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By: /s/ Frank Bedu-Addo, Ph.D.
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Name: Frank Bedu-Addo, Ph.D.
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Title: President and Chief Executive Officer
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| • |
Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7 in Chicago:
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| • |
The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1
therapy KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
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| • |
The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2
clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.
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| • |
In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate
Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.
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| • |
Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.
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March 31, 2022
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December 31,
2021
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|||||||
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ASSETS
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(unaudited)
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|||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$
|
58,881,101
|
$
|
65,242,622
|
||||
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Prepaid expenses and other
|
1,849,406
|
1,597,569
|
||||||
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Total current assets
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60,730,507
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66,840,191
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||||||
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Property and equipment, net
|
-
|
86
|
||||||
|
Operating lease right-to-use asset
|
308,327
|
357,611
|
||||||
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Total assets
|
$
|
61,038,834
|
$
|
67,197,888
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||||
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LIABILITIES AND STOCKHOLDERS' EQUITY
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||||||||
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Current liabilities:
|
||||||||
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Accounts payable
|
$
|
2,745,709
|
$
|
1,309,403
|
||||
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Accrued expenses
|
1,961,468
|
2,187,704
|
||||||
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Operating lease obligation-short term
|
311,311
|
258,924
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||||||
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Total current liabilities
|
5,018,488
|
3,756,031
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||||||
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Noncurrent liability:
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||||||||
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Operating lease obligation-long term
|
146,980
|
231,430
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||||||
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Total Liabilities:
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$
|
5,165,468
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$
|
3,987,461
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||||
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STOCKHOLDERS' EQUITY
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||||||||
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Common stock, $0.00033 par value, 75,000,000
shares authorized at March 31, 2022 and December 31, 2021, 28,450,894 shares and 28,448,612 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively
|
9,388
|
9,387
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||||||
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Additional paid-in capital
|
125,041,062
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123,904,602
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||||||
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Accumulated deficit
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(69,177,084
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)
|
(60,703,562
|
)
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||||
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Total stockholders' equity
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55,873,366
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63,210,427
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||||||
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||||||||
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Total liabilities and stockholders' equity
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$
|
61,038,834
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$
|
67,197,888
|
||||
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Three Months Ended March 31,
|
||||||||
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2022
|
2021
|
|||||||
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Operating expenses:
|
||||||||
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Research and development expenses
|
$
|
5,161,315
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$
|
1,413,057
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||||
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General and administrative expenses
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3,317,907
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1,636,216
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||||||
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Total operating expenses
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8,479,222
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3,049,273
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||||||
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Loss from operations
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(8,479,222
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)
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(3,049,273
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)
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||||
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Other income
|
||||||||
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Interest income
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5,700
|
655
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||||||
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Net loss and comprehensive loss
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$
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(8,473,522
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)
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$
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(3,048,618
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)
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Per share information:
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||||||||
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Net loss per share, basic
|
$
|
(0.32
|
)
|
$
|
(0.14
|
)
|
||
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Net loss per share, diluted
|
$
|
(0.32
|
)
|
$
|
(0.14
|
)
|
||
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Weighted average common shares outstanding, basic
|
26,161,156
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22,263,838
|
||||||
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Weighted average common shares outstanding, diluted
|
26,161,156
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22,263,838
|
||||||
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Three Months Ended March
31,
|
||||||||
|
2022
|
2021
|
|||||||
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Cash flows from operating activities:
|
||||||||
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Net loss
|
$
|
(8,473,522
|
)
|
$
|
(3,048,618
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)
|
||
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Adjustments to reconcile net loss to net cash used in operating activities:
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||||||||
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Stock-based compensation expense
|
1,128,973
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257,622
|
||||||
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Stock-based 401K company common match
|
-
|
35,747
|
||||||
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Depreciation expense
|
86
|
1,860
|
||||||
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Operating lease expense
|
60,257
|
60,257
|
||||||
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Changes in assets and liabilities:
|
||||||||
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Prepaid expenses and other assets
|
(251,837
|
)
|
(721,849
|
)
|
||||
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Accounts payable
|
1,436,306
|
(464,626
|
)
|
|||||
|
Accrued expenses
|
(226,236
|
)
|
119,473
|
|||||
|
Operating lease liabilities
|
(43,036
|
)
|
(42,057
|
)
|
||||
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Net cash used in operating activities
|
(6,369,009
|
)
|
(3,802,191
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)
|
||||
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Cash flow from financing activities:
Proceeds from exercise of stock options
|
7,488
|
-
|
||||||
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Net cash provided by financing activities
|
7,488
|
-
|
||||||
|
Net decrease in cash and cash equivalents
|
(6,361,521
|
)
|
(3,802,191
|
)
|
||||
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Cash and cash equivalents at beginning of period
|
65,242,622
|
28,839,565
|
||||||
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Cash and cash equivalents at end of period
|
$
|
58,881,101
|
$
|
25,037,374
|
||||