PDS Biotechnology Corp. Files 2023 Annual Report on Form 10-K

TL;DR

<b>PDS Biotechnology Corp. has filed its annual 10-K report for the fiscal year ended December 31, 2023, detailing its business operations and financial standing.</b>

AI Summary

PDS Biotechnology Corp (PDSB) filed a Annual Report (10-K) with the SEC on March 28, 2024. PDS Biotechnology Corp. filed its 10-K report for the fiscal year ending December 31, 2023. The company's principal executive offices are located at 303A College Road East, Princeton, NJ 08540. PDS Biotechnology Corp. was formerly known as Edge Therapeutics, Inc., with a name change on September 11, 2009. The filing covers the fiscal year from January 1, 2023, to December 31, 2023. The SIC code for PDS Biotechnology Corp. is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking PDS Biotechnology Corp, this filing contains several important signals. This 10-K filing provides a comprehensive overview of PDS Biotechnology Corp.'s financial performance, strategic initiatives, and risk factors for the fiscal year 2023, which is crucial for investors to assess the company's current health and future prospects. Understanding the company's historical data, including its former name and business address, provides context for its evolution and operational base, aiding in a more informed investment decision.

Risk Assessment

Risk Level: low — PDS Biotechnology Corp shows low risk based on this filing. The risk is low as this is a standard annual report filing (10-K) which primarily contains historical financial data and business descriptions, without immediate new material events or significant financial distress indicators.

Analyst Insight

Review the full 10-K filing to understand PDS Biotechnology Corp.'s financial performance, strategic direction, and any disclosed risks for the fiscal year 2023.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-28 — Filing Date (As of date)
• 2834 — SIC Code (Standard Industrial Classification)
• 001-37568 — SEC File Number (SEC file number)

Key Players & Entities

• PDS Biotechnology Corp. (company) — Filer name
• Edge Therapeutics, Inc. (company) — Former company name
• 2023 (date) — Fiscal year end
• 20240328 (date) — Filing date
• 303A College Road East, Princeton, NJ 08540 (address) — Business address
• 2834 (industry_code) — Standard Industrial Classification

FAQ

Industry Context

PDS Biotechnology Corp. operates within the Pharmaceutical Preparations industry, focusing on the development and commercialization of biopharmaceutical products.

Regulatory Implications

The company is subject to standard SEC regulations for public companies, including the requirement to file annual reports (10-K) detailing its financial health and business operations.

What Investors Should Do

1. Analyze the financial statements within the 10-K for revenue, net income, and cash flow trends.
2. Review the 'Risk Factors' section for any new or evolving risks specific to PDS Biotechnology Corp.'s operations or market.
3. Examine management's discussion and analysis (MD&A) for insights into the company's strategy and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K filing.
• 2024-03-28: Filing Date — Date the 10-K report was officially submitted to the SEC.

Year-Over-Year Comparison

This filing is the annual 10-K for fiscal year 2023, following previous quarterly (10-Q) and annual (10-K) filings which would contain comparative data.

Key Financial Figures

• $0.00033 — ich registered Common Stock, par value $0.00033 per share PDSB The NASDAQ Stock Mar

Filing Documents

• ef20015299_10k.htm (10-K) — 2003KB
• ef20015299_ex10-26.htm (EX-10.26) — 142KB
• ef20015299_ex10-27.htm (EX-10.27) — 137KB
• ef20015299_ex19.htm (EX-19) — 109KB
• ef20015299_ex21-1.htm (EX-21.1) — 3KB
• ef20015299_ex23-1.htm (EX-23.1) — 4KB
• ef20015299_ex31-1.htm (EX-31.1) — 14KB
• ef20015299_ex31-2.htm (EX-31.2) — 14KB
• ef20015299_ex32-1.htm (EX-32.1) — 6KB
• ef20015299_ex32-2.htm (EX-32.2) — 6KB
• ef20015299_ex97.htm (EX-97) — 20KB
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• image00017.jpg (GRAPHIC) — 2KB
• 0001140361-24-016265.txt (&nbsp;) — 8178KB
• pdsb-20231231.xsd (EX-101.SCH) — 41KB
• pdsb-20231231_cal.xml (EX-101.CAL) — 54KB
• pdsb-20231231_def.xml (EX-101.DEF) — 212KB
• pdsb-20231231_lab.xml (EX-101.LAB) — 663KB
• pdsb-20231231_pre.xml (EX-101.PRE) — 376KB
• ef20015299_10k_htm.xml (XML) — 744KB

Business

Business 4 Item 1A

Risk Factors

Risk Factors 48 Item 1B Unresolved Staff Comments 86 Item 1C Cybersecurity 86 Item 2

Properties

Properties 86 Item 3

Legal Proceedings

Legal Proceedings 86 Item 4 Mine Safety Disclosures 86 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuers Purchases of Equity Securities 87 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 88 Item 7A Qualitative and qualitative disclosures about market risk 102 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 102 Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 103 Item 9A

Controls and Procedures

Controls and Procedures 103 Item 9B Other Information 103 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 103 PART III Item 10 Directors, Executive Officers and Corporate Governance 104 Item 11

Executive Compensation

Executive Compensation 104 Item 12 Securities Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 104 Item 13 Certain Relationships and Related Transactions and Director Independence 104 Item 14 Principal Accountant Fees and Services 104 PART IV Item 15 Exhibits and Financial Statement Schedules 104 Item 16 Form 10-K Summary 104

Signatures

Signatures 108 Index Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K (this "Annual Report") contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company's management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," "forecast," "guidance", "outlook" and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation. the Company's ability to protect its intellectual property rights; the Company's anticipated capital requirements, including the Company's anticipated cash runway and the Company's current expectations regarding its plans for future equity financings; the Company's dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company's operations or require the Company to relinquish rights to the Company's technologies or product candidates; the Company's limited operati

Business

Business Company Overview We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies based on our Versamune T cell-activator and Versamune in combination with our interleukin 12 (IL-12) fused antibody drug conjugate (ADC), PDS01ADC, a tumor targeting immunocytokine. In addition, we are developing the Infectimune T cell-activator in infectious diseases. We believe our investigational targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through effective conversion of the immune suppressive tumor to an immunogenic microenvironment in addition to the induction of the right type, potency and quantity of tumor-targeting killer (CD8) T cells. Our Versamune immunotherapies and Versamune in combination with PDS01ADC, are utilized for treatments in oncology, and Infectimune is utilized for preventive vaccines against infectious agents. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune and Infectimune have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional disease-specific CD4 helper and CD8 killer T cells, a specific sub-type of T cell that has shown potential to be more effective at killing infected or target cells. Infectimune is also designed to promote the induction of disease-specific neutralizing antibodies. PDS01ADC is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment and reduces the prevalence of immune suppressive cells and components within the tumor. We believe that our proprietary combination of Versamune and PDS01ADC may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and work synergistically to inhibit or treat cancer. In November 2022, we announced the presentat

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View this 10-K filing on SEC EDGAR