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PDS Biotechnology Corporation reported that Nasdaq has notified the company its common stock no longer meets the $1.00 minimum bid price required to remain listed on The Nasdaq Capital Market. The closing bid has stayed below $1.00 for 30 straight business days.
The stock continues trading under the symbol PDSB while the company has 180 calendar days, until August 24, 2026, to regain compliance by posting a closing bid of at least $1.00 for at least 10 consecutive business days. If it still fails to comply, Nasdaq may grant a second 180‑day period if other listing standards are met.
If compliance is not restored, the shares could ultimately be delisted, although the company would have the right to appeal any delisting decision. PDS Biotechnology plans to monitor its share price and may consider options such as a reverse stock split, but there is no assurance it will regain compliance.
PDS Biotechnology Corporation filed a Form 8-K to share its updated February 2026 corporate presentation. The deck focuses on PDS0101, a Versamune-based immunotherapy targeting HPV16-positive head and neck cancers, and PDS01ADC, a tumor-targeted IL-12 immunocytokine.
PDS0101 plus pembrolizumab in first-line HPV16-positive recurrent/metastatic head and neck cancer showed a median overall survival of 39.3 months, compared with a 12–18 month benchmark for pembrolizumab-based regimens, a 77.4% disease control rate, and a 35.8% objective response rate. Treatment-related adverse events were mostly grade 1–2.
The company highlights a pivotal Phase 3 VERSATILE-003 trial with progression-free survival as the primary endpoint for accelerated approval, multiple Phase 2 studies of PDS01ADC across prostate, colorectal, and liver-associated cancers, and more than 12 patent families providing PDS0101 exclusivity through 2042/2043 in key global markets.
PDS Biotechnology Corporation has adopted an amended protocol for its Phase 3 VERSATILE-003 trial of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. The amendment designates progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway, while median overall survival (mOS) remains the primary endpoint for full approval. After the FDA’s standard 30-day review of the amended protocol to the IND without objection, the company is proceeding under the new design, which it believes may shorten trial duration and make the study more cost efficient.
PDS Biotechnology Corporation reported that results from a National Cancer Institute-led study of its investigational Interleukin-12 (IL-12) tumor-targeted immunocytokine, PDS01ADC, were presented at a major prostate cancer research conference. The presentation took place at an American Association of Cancer Research special conference in Boston, covering meetings held January 20-22, 2026.
The company issued a press release on January 28, 2026 to share this update, and that release is attached as an exhibit to the filing, providing more detail on the study and its findings.
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.