Welcome to our dedicated page for Pds Biotechnology Corporation SEC filings (Ticker: PDSB), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
PDS Biotechnology Corporation filings document the formal disclosures of a late-stage biotechnology company developing targeted immunotherapies for cancer. Recent 8-K reports furnish operating and financial results, business updates, corporate presentations, and press-release exhibits covering PDS0101, VERSATILE-003, PDS01ADC, and related clinical and biomarker data.
The filing record also includes material-event disclosures on FDA and IND protocol matters, Nasdaq listing-compliance correspondence, exhibit filings, capital-structure topics, shareholder voting matters, and the risk and forward-looking-statement language attached to the company’s clinical-development and financing activities.
PDS Biotechnology Corporation reported that the U.S. Patent Office has issued a Notice of Allowance for a patent covering its lead asset, PDS0101. A Notice of Allowance means the patent application has been approved and a patent is expected to be granted once final formalities and fees are completed.
The company highlighted this development in a press release attached to the report. Strengthening patent protection around a lead drug candidate can help secure future commercial exclusivity if the product is successfully developed and approved, although this filing does not provide clinical or financial details.
PDS Biotechnology Corporation reported that it has submitted a protocol amendment to the U.S. Food and Drug Administration for its Phase 3 VERSATILE-003 clinical trial of PDS0101. The amendment would make progression free survival the primary endpoint that can be evaluated earlier with significant statistical power, which may provide a basis for accelerated approval of PDS0101. Median overall survival remains the primary endpoint for full approval, consistent with the FDA’s original recommendation.
PDS Biotechnology (PDSB) filed its Q3 2025 report, showing continued operating losses and tighter liquidity. Cash and cash equivalents were $26.2 million as of September 30, 2025, down from $41.7 million at year-end. The company reported a Q3 net loss of $9.0 million and a nine‑month net loss of $26.9 million, with Q3 loss per share of $0.19. Operating expenses fell year over year to $8.1 million, driven by lower R&D and steady G&A.
PDS completed financings to support operations. In February, it raised approximately $10.05 million net via common stock, pre‑funded warrants, and warrants. On April 30, it issued $22,222,222 senior secured convertible debentures for a $20 million purchase price, using about $19 million to retire prior debt; the debentures carry a variable coupon (prime +5%) and had an effective annual interest rate ~24.1% as of quarter‑end, with lenders able to require up to $500,000 monthly redemptions; $1.0 million was redeemed in Q3. The company also sold 1,072,080 shares under its ATM for $1.3 million net in Q3 and, subsequently on November 11, raised approximately $4.8 million net in a registered direct offering.
Management disclosed substantial doubt about continuing as a going concern, citing ongoing losses, no revenues, and minimum cash covenants under the debentures. Common shares outstanding were 47,705,442 at September 30, 2025, and 48,980,307 as of November 6, 2025.
PDS Biotechnology (PDSB) filed an 8-K stating it furnished a press release with updates to its clinical programs and its financial results for the quarter ended September 30, 2025.
The press release is attached as Exhibit 99.1. The company notes the information is “furnished” and not “filed” under the Exchange Act and is not subject to Section 18 liability or incorporated by reference except as expressly set forth.
PDS Biotechnology (PDSB) entered a registered offering, agreeing to sell 5,741,000 shares at $0.91, 59,000 pre-funded warrants (exercise price $0.0001), and 5,800,000 common warrants at $1.00 per share. The common warrants are exercisable beginning six months after issuance and expire five years from initial exercise.
The transaction is expected to generate gross proceeds of up to approximately $11.1 million, assuming full cash exercise of the common warrants, with net proceeds up to approximately $10.4 million. The company plans to use proceeds for research and development and general corporate purposes. Directors and executive officers agreed to 60-day lock-ups; the company agreed to a 45-day no-issuance period and a six-month restriction on variable rate transactions, with ATM activity permitted after 45 days under an existing agreement.
PDS also agreed to amend existing warrants covering up to 5,948,334 shares, reducing the exercise price from $1.50 to $1.00, exercisable starting six months after closing. Craig-Hallum will act as placement agent for a 6.0% cash fee on shares and pre-funded warrants, plus up to $100,000 in expenses. The offering is under an effective Form S-3, supplemented by a prospectus dated November 12, 2025.
PDS Biotechnology (PDSB) launched a primary best‑efforts offering of 5,741,000 shares of common stock at $0.91 per share, together with pre‑funded warrants to purchase up to 59,000 shares at $0.9099 and common warrants to purchase up to 5,800,000 shares at a $1.00 exercise price. This supplement also registers up to 5,859,000 shares issuable upon exercise of the pre‑funded and common warrants.
The common warrants become exercisable six months after issuance and expire five years from their initial exercise date; pre‑funded warrants are immediately exercisable at $0.0001. Gross proceeds are $5,277,994.10, placement agent fees are $316,680.00, and proceeds before expenses are $4,961,314.10. Craig‑Hallum Capital Group LLC is sole placement agent. Net proceeds are intended for research and development and general corporate purposes.
The company reports approximately $26.2 million of cash and cash equivalents for the three months ended September 30, 2025. Shares outstanding are expected to be 52,374,362 immediately after the offering. Certain February 2025 warrants to purchase up to 5,948,334 shares will have their exercise price reduced to $1.00, effective upon closing.
PDS Biotechnology (PDSB) filed an 8-K noting a press release about positive clinical and translational data presented at the 2025 Society for Immunotherapy of Cancer Annual Meeting. The presentations focus on immune-driven mechanisms and biomarkers tied to the company’s investigational HPV16-targeted immunotherapy PDS0101 and its novel, investigational immunocytokine PDS01ADC.
The company states these findings help explain the programs’ strong clinical activity. A full copy of the press release is furnished as Exhibit 99.1.
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 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.