Delaware
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001-37568
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26-4231384
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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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☐
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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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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☐
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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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Common Stock, par value $0.00033 per share
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PDSB
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The Nasdaq Capital Market
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Item 2.02
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Results of Operations and Financial Conditions.
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Item 9.01
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Financial Statements and Exhibits.
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Exhibit
Number
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Description
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Press release dated August 13, 2020.
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PDS BIOTECHNOLOGY CORPORATION
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||
Date: August 13, 2020
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By:
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/s/ Frank Bedu-Addo, Ph.D.
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Name:
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Frank Bedu-Addo, Ph.D.
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Title:
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President and Chief Executive Officer
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• |
Announced publication of PDS0101 triple combination preclinical study by the National Cancer Institute;
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• |
Initiated Phase 2 clinical trial of PDS0101 triple combination, led by the National Cancer Institute, for the treatment of advanced human papillomavirus
(HPV)-associated cancers;
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• |
Announced Phase 2 trial to evaluate PDS0101 in combination with standard of care for treatment of locally advanced cervical cancer at The University of Texas MD
Anderson Cancer Center;
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• |
Launched novel PDS Biotech-owned vaccine development programs for COVID-19, PDS0203, and universal influenza, PDS0202;
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• |
Broadened existing co-development agreement with Farmacore Biotechnology to include development of a second COVID-19 vaccine candidate, PDS0204;
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• |
Expanded existing Cooperative Research and Development Agreement with the National Cancer Institute to include preclinical and clinical development of PDS0103 in MUC-1
expressing- cancers including breast, colon, lung and ovarian cancers;
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• |
PDS Biotech collaborator at the University of Kentucky School of Medicine granted NIAID award to accelerate Versamune(R)-based PDS0202 universal influenza vaccine;
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• |
Published abstract on preclinical studies of PDS0102, a product for the treatment of breast and prostate cancers, at the American Society of Clinical Oncology; and
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• |
Appointed Dr. Ilian Iliev to Board of Directors.
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June 30, 2020
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December 31, 2019
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|||||||
ASSETS
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(unaudited)
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|||||||
Current assets:
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||||||||
Cash and cash equivalents
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$
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16,934,495
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$
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12,161,739
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||||
Prepaid expenses and other
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2,506,646
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2,308,462
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||||||
Total current assets
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19,441,141
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14,470,201
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||||||
Property and equipment, net
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13,247
|
21,051
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||||||
Right-to-use asset
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638,831
|
–
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||||||
Total assets
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$
|
20,093,219
|
$
|
14,491,252
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
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||||||||
LIABILITIES
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||||||||
Current liabilities:
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||||||||
Accounts payable
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$
|
1,092,527
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$
|
1,197,720
|
||||
Accrued expenses
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1,194,358
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1,097,640
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||||||
Restructuring reserve
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126,862
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498,185
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||||||
Operating lease liability - short term
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112,657
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–
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||||||
Total current liabilities
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2,526,404
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2,793,545
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||||||
noncurrent liability:
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||||||||
Operating lease liability - long term
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552,326
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–
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||||||
STOCKHOLDERS' EQUITY
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||||||||
Common stock, $0.00033 par
value, 75,000,000 shares authorized at June 30, 2020 and December 31, 2019, 15,361,619 shares and 5,281,237 shares issued and
outstanding at June 30, 2020 and December 31, 2019, respectively
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5,064
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1,742
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||||||
Additional paid-in capital
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52,861,882
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40,633,670
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||||||
Accumulated deficit
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(35,852,457
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)
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(28,937,705
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)
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||||
Total stockholders' equity
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17,014,489
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11,697,707
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||||||
Total liabilities and stockholders' equity
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$
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20,093,219
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$
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14,491,252
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Three Months Ended June 30,
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Six Months Ended June 30,
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|||||||||||||||
2020
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2019
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2020
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2019
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|||||||||||||
Operating expenses:
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||||||||||||||||
Research and development expenses
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$
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1,414,225
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$
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1,886,934
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$
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3,385,904
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$
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2,916,937
|
||||||||
General and administrative expenses
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1,521,736
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2,383,972
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3,581,884
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6,289,848
|
||||||||||||
Total operating expenses
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2,935,961
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4,270,906
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6,967,788
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9,206,785
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||||||||||||
Loss from operations
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(2,935,961
|
)
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(4,270,906
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)
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(6,967,788
|
)
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(9,206,785
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)
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||||||||
Other income (expense):
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||||||||||||||||
Gain on bargain purchase upon merger
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–
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209,449
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–
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11,939,331
|
||||||||||||
Interest income
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6,617
|
175,605
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53,036
|
198,907
|
||||||||||||
Interest expense
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–
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–
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–
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(606
|
)
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|||||||||||
Net loss and comprehensive loss
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(2,929,344
|
)
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(3,885,852
|
)
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(6,914,752
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)
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2,930,847
|
|||||||||
Per share information:
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||||||||||||||||
Net loss per share, basic
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$
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(0.19
|
)
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$
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(0.75
|
)
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$
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(0.54
|
)
|
$
|
0.66
|
|||||
Net loss per share, diluted
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$
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(0.19
|
)
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$
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(0.75
|
)
|
$
|
(0.54
|
)
|
$
|
0.52
|
|||||
Weighted average common shares outstanding, basic
|
$
|
15,357,199
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$
|
5,175,837
|
$
|
12,835,980
|
$
|
4,466,025
|
||||||||
Weighted average common shares outstanding, diluted
|
$
|
15,357,199
|
$
|
5,175,837
|
$
|
12,835,980
|
$
|
5,677,360
|