Skip to main content

PDS Biotechnology Corp

For the period ended Dec 31, 2024. Filed Mar 27, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 27, 2025

PDSB$1.08-12.2%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits

Item 6. [Reserved]

Item 7Management’s Discussion and Analysis of Financial Condition and Results of Operations91
Item 7AQualitative and qualitative disclosures about market risk107
Item 8Financial Statements and Supplementary Data107
Item 9Changes in and Disagreements with Accountants on Accounting and Financial Disclosure107
Item 9AControls and Procedures107
Item 9BOther Information108
Item 9CDisclosure Regarding Foreign Jurisdictions that Prevent Inspections108
PART III
Item 10Directors, Executive Officers and Corporate Governance109
Item 11Executive Compensation109
Item 12Securities Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters109
Item 13Certain Relationships and Related Transactions and Director Independence109
Item 14Principal Accountant Fees and Services109
PART IV
Item 15Exhibits and Financial Statement Schedules109
Signatures114

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 ability to continue as a going concern and its dependence on additional financing to fund its operations and complete the development and commercialization of its clinical and 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 clinical and product candidates;
●the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan;
●the timing for the Company or its partners to initiate the planned clinical trials for its Versamune® products, including Versamune® HPV, PDS0103, and others, alone or in combination with PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12), as well as Infectimune® based products and the future success of such trials;
●the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune®, PDS01ADC and Infectimune® based clinical and product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s clinical and product candidates;
●the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including its ability to fully fund its disclosed clinical trials, which assumes no material changes to its currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;
●expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of the Company’s clinical and product candidates;
●any Company statements about its understanding of product candidates’ mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved;
●the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and
●other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including those listed under Part II, Item 1A. Risk Factors.

Any forward-looking statements in this Annual Report reflect the Company’s current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, the Company assumes no obligation to update or revise these forward-looking statements for any reason, whether as a result of new information, future events or otherwise.

In this Annual Report, unless otherwise stated or the context otherwise indicates, references to “PDS Biotech,” “the Company,” “we,” “us,” “our” and similar references refer to PDS Biotechnology Corporation, a Delaware corporation.

Index

Part I

Unless the context requires otherwise, references in this report to “PDS Biotech,” “Company,” “we,” “us,” and “our” and similar designations refer to PDS Biotechnology Corporation and our subsidiary.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.