PDS Biotechnology Corp (PDSB) SEC Filings, Jul-Nov 2025

PDS Biotechnology (PDSB) filed an 8-K announcing a regulatory step for its lead immunotherapy. The company said it has requested a meeting with the U.S. Food and Drug Administration to explore an expedited approval pathway for PDS0101 in HPV16+ head and neck cancer. The announcement was made via a press release furnished as Exhibit 99.1.

This update signals the company’s intent to discuss potential accelerated routes with regulators, which, if granted in the future, could affect how quickly PDS0101 reaches patients. The filing does not include additional program, timing, or financial details beyond the meeting request.

PDS Biotechnology Corporation filed an 8-K stating that on September 18, 2025 it issued a press release detailing a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) drawn from the final data of its VERSATILE-002 Phase 2 clinical trial. The filing itself does not include the press release text or any efficacy, safety, or numerical outcome data; it only identifies the press release as Exhibit 99.1 and incorporates it by reference. This disclosure notifies investors that the company is reporting subgroup findings for a defined low PD-L1 population but provides no performance metrics, so readers must consult the Exhibit for results.

PDS Biotechnology Corporation (PDSB) filed a Form S-3 shelf registration to offer, from time to time, up to $200.0 million of securities in various forms, including a separate sales agreement prospectus for up to $20.0 million of common stock under an Amended and Restated At Market Issuance Sales Agreement dated August 13, 2024. The company also has an at-the-market sales agreement allowing up to $50.0 million of common stock through B. Riley Securities and H.C. Wainwright; $5.7 million has been sold under that agreement to date. Common stock traded at $1.28 on August 27, 2025, and public float was approximately $60.7 million based on 45,614,111 shares at $1.33 on July 3, 2025. The filing discloses potential dilution from outstanding equity-linked instruments, including 6,397,184 options, 8,757,034 warrants, and up to 8,818,340 shares issuable upon conversion of senior secured convertible debentures totaling $22,222,222. The company warns of dependence on additional financing, limited operating history, and the uncertainty of ongoing clinical programs.

PDS Biotechnology Corporation filed a current report to note that it has updated its corporate presentation deck. The new presentation, dated August 2025, is provided as Exhibit 99.1 and is incorporated by reference, meaning it is intended to be used as part of the company’s formal public disclosures. The filing does not describe financial results or new transactions, but signals that the company is refreshing the materials it uses to communicate its business, pipeline, and strategy to the market.

PDS Biotechnology Corporation filed a report describing that it has issued a press release with final topline survival data from its VERSATILE-002 Phase 2 clinical trial. This study evaluated its immunotherapy candidate PDS0101 (Versamune® HPV) in combination with Keytruda® (pembrolizumab) for patients with HPV16-positive, first-line recurrent or metastatic head and neck squamous cell cancer. The company has attached the full press release as Exhibit 99.1 for more detailed clinical results.

Armistice Capital, LLC and Steven Boyd report beneficial ownership of 2,283,288 shares of PDS Biotechnology Corp (CUSIP 70465T107), representing 4.99% of the outstanding common stock. The filing states that Armistice Capital is the investment manager of Armistice Capital Master Fund Ltd., the direct holder of the shares, and that Armistice Capital and Mr. Boyd exercise shared voting and dispositive power over the reported shares while having no sole voting or dispositive power.

The Reporting Persons certify the shares were acquired in the ordinary course of business and not for the purpose of changing or influencing control of the issuer. The Schedule 13G/A is executed jointly by Armistice Capital and Steven Boyd and dated August 14, 2025.

PDS Biotechnology reported $31.9 million in cash and cash equivalents and a consolidated net loss of $9.4 million for the quarter and $17.9 million for the six months ended June 30, 2025. Total assets were $40.5 million and total liabilities were $24.5 million, leaving stockholders' equity of $16.0 million and an accumulated deficit of $200.0 million. Shares outstanding increased to 46,633,362. The company used $18.1 million of cash in operating activities during the first half of 2025 and reduced cash from $41.7 million at year-end 2024 to $31.9 million at June 30, 2025.

PDSB completed financings in early 2025, including a February offering that generated net proceeds of about $10.05 million and a securities purchase agreement that raised $20.0 million (including $22.22 million principal debentures) used largely to retire prior debt. The debentures carry a high effective annual interest rate (~24.1%) and include cash-maintenance and customary restrictive covenants. The company disclosed substantial doubt about its ability to continue as a going concern for at least 12 months. Clinically, PDSB advanced VERSATILE-003 into Phase 3 and reported multiple encouraging trial updates and a JAMA Oncology publication showing strong survival and response results in certain cohorts.

PDS Biotechnology Corporation filed a current report stating that it issued a press release on August 13, 2025 providing an update on its clinical programs and financial results for the quarter ended June 30, 2025. The report explains that the press release is attached as Exhibit 99.1 and is being treated as information that is furnished rather than filed under securities law, which affects the level of legal liability associated with it. The filing itself does not detail the results or clinical data, but directs readers to the attached press release for those specifics.