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 Stock Market LLC
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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 November 14, 2024.
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Corporate Presentation (November 2024).
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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PDS BIOTECHNOLOGY CORPORATION
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Date: November 14, 2024
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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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• |
Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC
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Updated trial design to include approximately 350 patients
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VERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year,
demonstrating durability of the anti-tumor responses
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The design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of our agreement with the FDA on
registrational design
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Design maintains 2:1 randomization and median overall survival as primary endpoint
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Design imparts potential for earlier interim readouts and study completion
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Design presents potential for reduced execution costs
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Amended IND (updated design) submitted November 2024
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In September 2024, we provided updated results from our VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of
Versamune® HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North
Carolina, and principal investigator of the VERSATILE-002 clinical trial. Press release here.
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In October 2024, we provided updated results from our IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune® HPV and
chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. Press release here.
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Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National
Institutes of Health presented the rationale and design of recurrent prostate cancer trial combining Xtandi® + PDS01ADC vs Xtandi® alone during an oral presentation at the 12th Annual Meeting of the
International Cytokine and Interferon Society, October 2024. Press release here .
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Three Months Ended Sep 30,
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Nine Months Ended Sep 30,
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|||||||||||||||
2024
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2023
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2024
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2023
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|||||||||||||
Operating expenses:
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||||||||||||||||
Research and development expenses
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$
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6,803,900
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$
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6,448,528
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$
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18,035,762
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$
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20,297,066
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||||||||
General and administrative expenses
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$
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3,374,794
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$
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4,071,158
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$
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10,924,863
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$
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12,341,207
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||||||||
Total operating expenses
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$
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10,178,694
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$
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10,519,686
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$
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28,960,625
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$
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32,638,273
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||||||||
Loss from operations
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$
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(10,178,694
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)
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$
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(10,519,686
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)
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$
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(28,960,625
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)
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$
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(32,638,273
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)
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||||
Interest income (expense), net
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||||||||||||||||
Interest income
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$
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666,770
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$
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739,404
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$
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2,010,874
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$
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2,219,399
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||||||||
Interest expense
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$
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(1,214,734
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)
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$
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(1,068,887
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)
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$
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(3,577,450
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)
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$
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(3,031,129
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)
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Interest income (expense), net
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$
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(547,964
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)
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$
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(329,483
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)
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$
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(1,566,576
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)
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$
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(811,730
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)
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Loss before income taxes
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$
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(10,726,658
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)
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$
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(10,849,169
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)
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$
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(30,527,201
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)
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$
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(33,450,003
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)
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Benefit for income taxes
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$
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869,169
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$
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1,406,021
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Net loss and comprehensive loss
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$
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(10,726,658
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)
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$
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(10,849,169
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)
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$
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(29,658,032
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)
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$
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(32,043,982
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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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(0.29
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)
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$
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(0.35
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)
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$
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(0.82
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)
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$
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(1.04
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)
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Weighted average common shares outstanding basic and diluted
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36,806,592
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30,910,520
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36,107,900
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30,715,458
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Sep 30,
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December 31,
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||||||
2024
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2023
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|||||||
Cash and cash equivalents
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$
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49,751,252
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$
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56,560,517
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Working capital
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$
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33,791,108
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$
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45,425,098
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Total assets
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$
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52,450,653
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$
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59,390,080
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Long term debt
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$
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12,031,986
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$
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19,506,183
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Accumulated deficit
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$
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(174,158,647
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)
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$
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(144,500,615
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)
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Total stockholders’ equity
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$
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22,000,805
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$
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26,130,947
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