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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☐ |
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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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 |
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, dated March 18, 2021.
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99.2 | PDS Corporate Presentation March 2021. |
PDS BIOTECHNOLOGY CORPORATION
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Date: March 18, 2021
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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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● |
Achieved preliminary efficacy benchmark in the Phase 2 combination trial of PDS0101 led by the National Cancer Institute.
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● |
Initiated VERSATILE-002, a Phase 2 trial of lead investigational drug candidate PDS0101, in combination with standard of care KEYTRUDA® for first-line treatment of patients with metastatic or recurrent HPV-positive head and neck
cancer.
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● |
Phase 2 trial of lead investigational drug candidate PDS0101, in combination with standard of care chemoradiotherapy for patients with advanced cervical cancer was initiated by the University of Texas MD Anderson Cancer Center.
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● |
Expanded consortium for development of PDS0203, a novel, Versamune®-based second-generation COVID-19 vaccine to include Blanver Farmoquímica in addition to Farmacore.
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● |
Received award commitment of up to $60 million from Brazil’s Ministry of Science, Technology and Innovation (MCTI) to fund clinical development and commercialization of PDS0203.
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● |
Strengthened leadership team with the appointment of Seth Van Voorhees as Chief Financial Officer and addition of preeminent oncologist Otis Brawley, M.D. to the board of directors.
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December 31,
2020
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December 31,
2019
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|||||||
ASSETS
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||||||||
Current assets:
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||||||||
Cash and cash equivalents
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$
|
28,839,565
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$
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12,161,739
|
||||
Prepaid expenses and other
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1,497,665
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2,308,462
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||||||
Total current assets
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30,337,230
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14,470,201
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||||||
Property and equipment, net
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5,443
|
21,051
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||||||
Operating lease right-to-use asset
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547,706
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–
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||||||
Total assets
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$
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30,890,379
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$
|
14,491,252
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||||||
Current liabilities:
|
||||||||
Accounts payable
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$
|
1,415,224
|
$
|
1,197,720
|
||||
Accrued expenses
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1,735,322
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1,097,640
|
||||||
Restructuring reserve
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–
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498,185
|
||||||
Operating lease obligation - short term
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119,904
|
-
|
||||||
Total current liabilities
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3,270,450
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2,793,545
|
||||||
Noncurrent liability:
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||||||||
Operating lease obligation - long term
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490,353
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–
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||||||
Total liabilities
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$
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3,760,803
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$
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2,793,545
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||||
STOCKHOLDERS’ EQUITY
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||||||||
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2020 and December 31, 2019, 22,261,619 shares and 5,281,237 shares issued and outstanding
at December 31, 2020 and December 31, 2019, respectively
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7,346
|
1,742
|
||||||
Additional paid-in capital
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70,907,315
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40,633,670
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||||||
Accumulated deficit
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(43,785,085
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)
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(28,937,705
|
)
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||||
Total stockholders’ equity
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27,129,576
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11,697,707
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||||||
|
||||||||
Total liabilities and stockholders' equity
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$
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30,890,379
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$
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14,491,252
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Year Ended December 31,
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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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7,924,450
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$
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6,099,580
|
||||
General and administrative expenses
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6,962,328
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10,981,765
|
||||||
Impairment expense IPRD
|
–
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2,974,000
|
||||||
Lease termination costs
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–
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979,273
|
||||||
Depreciation
|
15,608
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–
|
||||||
Total operating expenses
|
14,902,386
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21,034,618
|
||||||
Loss from operations
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(14,902,386
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)
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(21,034,618
|
)
|
||||
Other income (expense):
|
||||||||
Gain on bargain purchase upon merger
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–
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13,334,568
|
||||||
Interest income
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55,006
|
353,490
|
||||||
Interest expense
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–
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(33,559
|
)
|
|||||
Loss before income taxes
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(14,847,380
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)
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(7,380,119
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)
|
||||
Income taxes (benefit)
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–
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(381,513
|
)
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|||||
Net loss and comprehensive loss
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$
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(14,847,380
|
)
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$
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(6,998,606
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)
|
||
Per share information:
|
||||||||
Net loss per share, basic and diluted
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$
|
(0.89
|
)
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$
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(1.44
|
)
|
||
Weighted average common shares outstanding basic and diluted
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16,745,044
|
4,868,079
|