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.
BRAWLEY OTIS W reported acquisition or exercise transactions in this Form 4 filing.
PDS Biotechnology Corp director Otis W. Brawley received a grant of stock options. He was awarded 54,876 Employee Stock Options (Right to Buy), recorded at a grant price of $0.00 per option. The options vest in full on the first anniversary of the grant date, contingent on his continued service as a director.
PDS Biotechnology Corp director Stephen C. Glover received a grant of employee stock options for 54,876 shares on January 12, 2026. The options have an exercise price of $0.00 per share and represent a right to buy the company’s stock.
According to the filing, the entire stock option grant vests and becomes fully exercisable on the first anniversary of the grant date, as long as Glover continues to serve as a director through that date. After this grant, he directly holds options covering 54,876 shares.
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.