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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 9.01 |
Financial Statements and Exhibits.
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Exhibit
Number
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Description
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Press Release March 28, 2023.
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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: March 28, 2023
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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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| ● |
Successful meeting with FDA to discuss registrational pathway for triple combination of PDS0101, PDS0301, and a commercial immune checkpoint inhibitor
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| ● |
100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation) in IMMUNOCERV trial for high-risk cervical cancer patients with tumors >5 cm in PDS0101 + CRT
based on preliminary data
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| ● |
Company to host conference call and webcast today, March 28, 2023, at 8:00 AM ET
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| ● |
PDS0101 Lead Drug Candidate
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| ○ |
VERSATILE-002 Phase 2 combination trial with Merck & Co.
Inc.’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer.
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| ■ |
Completed first stage of enrollment in checkpoint inhibitor refractory arm
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| ■ |
Presented initial data on methods for investigating efficacy of PDS0101 in combination with KEYTRUDA® (pembrolizumab) with respect to T cell activation and functionality at the ESMO
Targeted Anticancer Therapies Congress 2023
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| ○ |
National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers.
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| ■ |
Successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)
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| ■ |
Reported median overall survival (OS) of 21 months in advanced, ICI refractory cancer HPV-positive patients (N=29) having few remaining treatment options
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| ○ |
IMMUNOCERV Phase 2 clinical trial of PDS0101 with
chemoradiotherapy (CRT) in patients with locally advanced cervical cancer.
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| ■ |
100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation), and 89% (8/9) complete response based on preliminary data
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| ■ |
Study demonstrated strong infiltration of T cells into the tumors, elimination of circulating tumor DNA
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| ● |
PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)
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| ○ |
Signed exclusive global license agreement for PDS0301, a novel, investigational, proprietary investigational tumor targeting, antibody-conjugated IL-12, developed by Merck KGaA, Darmstadt, Germany
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| ○ |
Publication of PDS0301 monotherapy study linking PDS0301-induced immune responses with clinical outcomes in International
Immunopharmacology
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| ● |
Infectimune™ Platform
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| ○ |
Publication of preclinical Infectimune™ study in the peer-reviewed journal Viruses showing complete protection in
animal studies with PDS0202, a novel investigational recombinant protein-based Universal flu vaccine
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| ○ |
A second preclinical Infectimune™ publication in the peer-reviewed journal Viruses showing unique induction of
higher levels of multifunctional CD4 T cells compared to leading commercial vaccine technologies
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December 31,
2022
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December 31,
2021
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|||||||
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ASSETS
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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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73,820,160
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$
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65,242,622
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||||
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Prepaid expenses and other
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2,660,230
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1,597,569
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||||||
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Total current assets
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76,480,390
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66,840,191
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||||||
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Property and equipment, net
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–
|
86
|
||||||
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Financing lease right-to-use assets
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374,888
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–
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||||||
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Operating lease right-to-use asset
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152,645
|
357,611
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||||||
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Total assets
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$
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77,007,923
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$
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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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||||||||
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Accounts payable
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$
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1,219,287
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$
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1,309,403
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||||
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Accrued expenses
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8,313,708
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2,187,704
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||||||
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Financing lease obligation - short term
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56,612
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–
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||||||
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Operating lease obligation - short term
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231,429
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258,924
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||||||
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Total current liabilities
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9,821,036
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3,756,031
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||||||
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Noncurrent liabilities:
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||||||||
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Note payable, net of debt discount
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23,020,844
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–
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||||||
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Financing lease obligation-long term
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164,013
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–
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||||||
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Operating lease obligation-long term
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–
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231,430
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||||||
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Total liabilities
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33,005,893
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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, $0.00033 par value, 75,000,000 shares authorized at December 31, 2022 and December 31, 2021,
30,170,317 shares and 28,448,612 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively
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9,956
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9,387
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||||||
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Additional paid-in capital
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145,550,491
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123,904,602
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||||||
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Accumulated deficit
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(101,558,417
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)
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(60,703,562
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)
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||||
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Total stockholders’ equity
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44,002,030
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63,210,427
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||||||
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Total liabilities and stockholders' equity
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$
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77,007,923
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$
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67,197,888
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||||
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Year Ended December 31,
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||||||||
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2022
|
2021
|
|||||||
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Operating expenses:
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||||||||
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Research and development expenses
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$
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29,431,027
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$
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11,254,538
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||||
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General and administrative expenses
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12,241,394
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10,184,773
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||||||
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Total operating expenses
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41,672,421
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21,439,311
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||||||
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Loss from operations
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(41,672,421
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)
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(21,439,311
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)
|
||||
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Interest income (expense), net
|
||||||||
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Interest income
|
935,180
|
4,346
|
||||||
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Interest expense
|
(1,316,519
|
)
|
-
|
|||||
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Interest income (expense), net
|
(381,339
|
)
|
4,346
|
|||||
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Loss before income taxes
|
(42,053,760
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)
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(21,434,965
|
)
|
||||
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Benefit from income taxes
|
1,198,905
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4,516,488
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||||||
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Net loss and comprehensive loss
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$
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(40,854,855
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)
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$
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(16,918,477
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)
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Per share information:
|
||||||||
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Net loss per share, basic and diluted
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$
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(1.43
|
)
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$
|
(0.66
|
)
|
||
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Weighted average common shares outstanding basic and diluted
|
28,599,221
|
25,597,125
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